Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury

Not Applicable

Completed

Conditions: Incomplete Spinal Cord Injury

Registration Number: NCT04340063

Lead Sponsor: VA Office of Research and Development

Brief Summary: Spinal cord injury (SCI) affects \~42,000 Veterans. The VA provides the single largest network of SCI care in the nation. The lifetime financial burden of SCI can exceed $3 million. A major cost of SCI is impaired mobility. Limited mobility contributes to decreased ability to work, increased care requirements, secondary injury, depression, bone mineral density loss, diabetes, and decreased cardiovascular health. Among ambulatory individuals with iSCI, residual balance deficits are common and are strongly correlated with both functional walking ability and participation in walking activities. The development of effective rehabilitation tools to improve dynamic balance would substantially improve quality of life for Veterans living with iSCI. Improving mobility through interventions that enhance dynamic balance would positively impact health, independence, and the ability to integrate into social, intellectual, and occupational environments.

Detailed Description: Background:

Among ambulatory individuals with incomplete spinal cord injury (iSCI), residual balance deficits are common and are a primary factor limiting participation in walking activities. There is broad recognition that effective evidence-based interventions are needed to enhance dynamic balance following iSCI. However, improving dynamic balance after iSCI has proven to be very challenging. Experimental interventions that amplify self-generated movements (e.g. error augmentation) may accelerate motor learning by intensifying sensory motor feedback and facilitating exploration of alternative motor control strategies. These features may be beneficial for retraining dynamic balance after iSCI. The investigators have developed a cable-driven robot to create a movement amplification environment during treadmill walking by applying a continuous viscous force field to the pelvis that is proportional in magnitude to a participant's real-time range of motion (ROM) velocity. The purpose is to investigate if locomotor training performed in a movement amplification environment can effectively improve dynamic balance and increase participation in walking activities of individuals with iSCI.

Specific Aims:

Aim 1: To evaluate if locomotor training performed in a movement amplification environment is effective for improving dynamic balance of individuals with iSCI. The investigators' pilot data found that following locomotor training performed in a movement amplification environment three individuals with iSCI each improved dynamic balance by more than 30%. These improvements were accompanied by faster over ground walking speeds and improved reactive balance. Thus, the investigators hypothesize that improvements in dynamic balance during walking will be greater when locomotor training is performed in a movement amplification environment when compared to locomotor training performed in a traditional treadmill environment.

Aim 2: To evaluate the impact of locomotor training performed in either a movement amplification environment or in a traditional treadmill environment on participation in walking activities. Based on evidence identifying a strong relationship between balance and steps per day in ambulatory individuals with iSCI, the investigators hypothesize that training in the movement amplification environment will positively impact dynamic balance, and in turn increase participating in walking activities.

Approach:

The investigators will conduct a two-arm parallel-assignment intervention and will enroll 36 ambulatory participants with chronic motor incomplete spinal cord injury. Participants will be randomized into either a Control group receiving locomotor training or an Experimental group receiving locomotor training performed in a movement amplification environment. All participants will receive 20 training sessions. The investigators will assess changes in dynamic balance using measures that span the International Classification of Functioning, Disability and Health (ICF) framework including; 1) clinical outcome measures of gait, balance, and quality of life, 2) biomechanical assessments of the capacity to control center of mass (COM) motion during walking, and 3) data collected from activity monitors to quantify changes in participation in walking activities as evaluated by number of steps taken per day.

Impact:

Training dynamic balance of individuals with iSCI by amplifying their own self-generated center of mass motion during walking is a radical departure from current practice and may create effective new clinical strategies for addressing balance impairments of individuals with iSCI. Successful outcomes from the proposed trial would motivate development of clinically-feasible tools to first replicate and then to evaluate the movement amplification environment within the VA's clinical care settings. Knowledge gained from this study will expand the understanding of how individuals with iSCI learn dynamic balance and how targeted dynamic balance training impacts participation in walking activities.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 38

Inclusion Criteria

Medically stable with medical clearance from a physician to participate
Neurologic level of the SCI between C1-T10 with American Spinal Injury Association (ASIA) Impairment Scale (AIS) C or D
> 6 months since initial injury
Passive range of motion of the legs within functional limits and not restricting the ability to engage in locomotor training
Able to ambulatory 10m with no physical assistance, use of assistive devices (e.g. single cane, rolling walker), and/or braces that do not cross the knee joint (e.g. ankle foot orthosis) are permitted
Able to provide transportation to and from the testing location.

Exclusion Criteria

Excessive spasticity in the lower limbs as measured by a score of > 3 on the Modified Ashworth Scale
Inability to tolerate 30 minutes of standing
Severe cardiovascular and pulmonary disease
History of recurrent fractures or known orthopedic problems in the lower extremities (i.e. heterotopic ossification)
Concomitant central or peripheral neurological injury (i.e. traumatic head injury or peripheral nerve damage in lower limbs)
Inability to provide informed consent due to cognitive impairments
Presence of unhealed decubiti or other skin compromise
Enrollment in concurrent physical therapy or research involving locomotor training
Use of braces/orthotics crossing the knee joint
Known pregnancy

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional Gait Assessment (FGA)	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The FGA is a ten-item test that evaluates dynamic balance and postural stability during gait. Each item on the test is scored from 0 (severe impairment) to 3 (normal ambulation). Total score of this test is 30, with higher score indicating better walking balance. Lowest possible score is 0.
Lateral Center of Mass Excursion	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average lateral center of mass excursion occurring each stride during treadmill walking.
Daily Stepping	Pre-training assessment (Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The investigators will assess the amount of daily stepping in the home and community during three 1-week periods. Daily stepping will be measured and recorded using an activity monitor. HIgher number of daily stepping indicates greater physical activity levels or greater walking in the community setting.

Secondary Outcome Measures

Name	Time	Method
10 Meter Walk Test (10MWT)_Fast Speed	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The 10MWT is a simple measurement of an individuals average walking speed.
10 Meter Walk Test (10MWT)_Preferred Speed	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The 10MWT is a simple measurement of an individuals average walking speed.
Activities Specific Balance Confidence (ABC) Scale	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The ABC scale is a 16-item self-report measurement of an individual's confidence while performing numerous postural and ambulatory activities. Each item is rated on a scale of 0 (no confidence) to 100 (complete confidence). Overall score is calculated by adding item scores and then dividing by the total number of items. Total score is 100. Higher score indicates greater balance confidence i.e. ability to perform tasks with less or no fear of falling. Lowest possible score is 0.
Balance Evaluations Systems Test (BESTest)	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The BESTest is used to assess balance impairments across six different domains of postural control. We will use only the reactive balance item from the BESTest to assess changes in the capacity to react to fore-aft, and lateral perturbations. Each item will be scored on a range from 0 (severe impairment) to 3 (no impairment). Highest score is 6 and lowest possible score is 0. Higher score indicates better ability to restore balance and better reactive stepping response during standing perturbation.
Berg Balance Scale (BBS)	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The BBS is a 14-item measure that assesses static balance. Each item is scored on a range of 0 to 4. A total score is determined by summing scores on the all the individual items. Total score is 56. Higher score indicates better static balance. Lowest possible score is 0.
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The ICIQ-UI SF is a 4-item self-report of urinary incontinence to document changes in bladder function. Scores range from 0-21, with greater values indicating increased severity.
Lower Extremity Motor Score	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The lower extremity motor score assess strength of five muscle groups representing neurological levels L2 to S1. Muscle function is grade on a range from 0 (total paralysis) to 5 (active movement, full range of motion (ROM) against gravity and sufficient resistance to be considered normal. Total score is 50. Higher score indicates better or more complete motor function in the lower extremities. Lowest possible score is 0.
Timed Up and Go (TUG)	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk. The participant sits in a chair with his/her back against the chair back. On the command "go," the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down. Time to complete the task is reported. Participant must use the same assistive device each time he/she is tested to be able to compare scores.
Walking Index for Spinal Cord Injury II (WISCI II)	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The WISCI II evaluates the amount of physical assistance needed for gait after spinal cord injury. The index ranges from 0 (client is unable to stand and/or participate in assisted walking) to 20 (ambulates with no devices, no braces and no physical assistance, 10 meters). Highest score is 20 and lowest possible score is 0. Higher score indicates better ability to ambulate at least a distance of 10 meters without assistance from assistive device and/or from other person.
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The physical domain focuses on patients perception about his physical health including items related to mobility, daily activities, functional capacity, energy, pain, and sleep. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0.
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The psychological domain focuses on patients perception about their psychological well-being, encompassing aspects like self-image, negative and positive feelings, self-esteem, and mental status. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0.
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The social relations domain focuses on patients perception about their social connections, support, and sexual life, contributing to their overall quality of life. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0.
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The environment domain focuses on patients perception about their surroundings, including factors like financial resources, safety, access to services, home environment, and the physical environment. social connections, support, and sexual life, contributing to their overall quality of life. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0.
Minimum Lateral Margin of Stability	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average minimum lateral margin of stability (distance between a velocity weighted whole body center of mass position and the edge of the base of support) occurring each step during treadmill walking.
Peak Lateral Center of Mass Speed	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average peak lateral center of mass speed occurring each stride during treadmill walking.
Step Width	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's preferred step width (lateral distance between calcaneal markers) during treadmill walking.
Step Length	Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)	The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's preferred step length (anterior - posterior distance between calcaneal markers) during treadmill walking.

Trial Locations

Locations (1): Edward Hines Jr. VA Hospital, Hines, IL
🇺🇸
Hines, Illinois, United States
Edward Hines Jr. VA Hospital, Hines, IL
🇺🇸Hines, Illinois, United States