Comparison of Intensity and Step Count of Gait Training Modalities in the Inpatient Rehabilitation Setting in Sub-acute Central Nervous System Injury
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Observation of Time spent in age-predicted moderate-intensity target heart rate zone
研究概览
简要总结
The purpose of the project is to compare intensity (minutes in target heart rate zone) and steps per session across three gait training modalities, including body-weight supported treadmill training (BWSTT), overground gait training with body weight-support (BWS), and overground gait training utilizing a lower extremity exoskeleton, between patients presenting with varying functional ambulation capacities in the inpatient setting. Additionally, the researchers will compare physical therapist (PT) burden across these modalities and patient functional presentation levels.
详细描述
Aim 1 of this study is to measure stepping repetition and intensity via heart rate of three gait-training modalities utilized with patients in the subacute phase of stroke and iSCI during inpatient rehabilitation in order to guide therapists through clinical decision-making of selecting the optimal intervention for patients based on functional presentation. Aim 2 of this study is to measure therapist burden across each gait training modalities, as this is an additional factor that contributes to the number of steps taken and intensity experienced by the patient.
The gait training modalities assessed will include BWSTT, overground gait training with a lower extremity exoskeleton, and overground gait training with BWS. The participants' functional level will be classified by gait speed obtained via the 10 meter walk test (10MWT), a standardized assessment commonly used in rehabilitation. These functional classification categories include household ambulator (low level) and limited community ambulator (high level), determined by Fritz et al. 2009.
The researchers hypothesize that low functioning/household ambulators will achieve more minutes in high-intensity training zones utilizing the exoskeleton due to the enhanced participation and increased weight-bearing the device supports compared to the other modalities. In addition, a greater number steps will be achieved in this mode due to the exoskeleton's ability to decrease overall therapist burden compared to BWSTT and overground with BWS. In contrast, the researchers anticipate that steps per session and overall intensity will be decreased in high functioning/limited community ambulators due the unnecessary support the exoskeleton provides at this functional level. The researchers believe that high functioning/ limited community ambulators will achieve the highest number of steps and intensity during BWSTT due to the ability to increase challenges via treadmill parameters such as speed and incline while utilizing a harness for safety and bodyweight support only as necessary. In contrast, the researchers believe the amount of BWS and assistance a PT must provide relative to the patient's contribution to practice successful stepping during BWSTT will result in a lower intensity and number of steps achieved in low functioning/household ambulators.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old, inclusive
- •Medical clearance from primary medical team (signed Medical Clearance form)
- •Adequate cognitive function as determined by the NIH scale: score ≤1 on question 1b and score =0 on question 1c
- •Gait speed between 0-0.79 m/s
- •Informed consent provided by participant or POA
- •English speaking
- •Additional Inclusion Criteria for patients post-stroke:
- •First stroke, ischemic or hemorrhagic, within the past six months
- •Unilateral, supratentorial stroke
- •Additional Inclusion Criteria for patients iSCI:
- •ASIA C or D
- •Traumatic iSCI, within past six months
- •Exclusion Criteria
- •Severe aphasia limiting ability to express needs or discomfort verbally or nonverbally
- •History of or concurrent neurologic condition (i.e., stroke, SCI, PD, TBI, MS, etc.)
- •History of peripheral nerve injury
- •Severe knee, hip, or ankle osteoarthritis
- •Severe osteoporosis as indicated by physician medical clearance
- •Open wounds on skin surfaces in contact with exoskeleton or harness
- •Unstable spine or unhealed fractures
- •Weight bearing precautions
- •Unresolved deep vein thrombosis (DVT)
- •Pregnancy
- •Prisoners
- •Additional Exclusion criteria for EksoNR13:
- •Weight >220 lbs (100 kg)
- •Height below 60 inches or above 76 inches
- •Standing hip width of approximately 18 inches or more
- •Joint contractures or range of motion deficits that limit normal range of motion during ambulation:
- •Knee flexion contracture greater than 12°
- •Hip flexion contracture greater than 17°
- •Inability to achieve 0° neutral ankle dorsiflexion with knee flexion up to 12°
- •Bilateral hip flexion less than 110°
- •Significant spasticity in the lower limbs (Modified Ashworth Scale ≥3)
- •Leg length discrepancy:
- •Greater than 0.5 in. (1.27 cm) for upper legs
- •Greater than 0.75 in. (1.91 cm) for lower legs
- •Active heterotopic ossification
- •Significant spasticity in the lower limbs (Modified Ashworth Scale ≥3)
- •High anxiety or claustrophobia
- •Clostridium difficile or other gastrointestinal isolation precautions
- •Colostomy
- •Uncontrolled autonomic dysreflexia
- •Lower limb prosthesis
排除标准
- 未提供
结局指标
主要结局
Observation of Time spent in age-predicted moderate-intensity target heart rate zone
时间窗: Each session through completion of study, up to 10 days
The target range of 50-70% of age-predicted maximum heart rate will be calculated for each participant utilizing HR max = 208 - \[0.7 × age\] as developed by Tanka et al in 2001. The target range of 50-70% of age-predicted maximum heart rate will be calculated for each participant. The researchers will record the amount of time participants spend in their pre-calculated target zone during each gait training. The minimum amount of time would be 0 minutes and the maximum amount of time would be 60 minutes as this would be the total time of the session. Less time spent in the moderate intensity pre-calculated target zone is a better outcome as the more minutes in the high intensity zone is the best outcome.
Observation of Time spent in age-predicted low-intensity target heart rate zone
时间窗: Each session through completion of study, up to 10 days
The target range of 50% of age-predicted maximum heart rate will be calculated for each participant utilizing HR max = 208 - \[0.7 × age\] as developed by Tanka et al in 2001. Low intensity equals 50% or less of age-predicted maximum heart rate and will be calculated for each participant. The researchers will record the amount of time participants spend in their pre-calculated target zone during each gait training. The minimum amount of time would be 0 minutes and the maximum amount of time would be 60 minutes as this would be the total time of the session. Less time spent in the low intensity zone is better as the goal is to achieve more minutes in high-intensity zone.
Observation of Step count
时间窗: Each session through completion of study, up to 10 days
The number of steps taken during each session will be measured using activity monitors/pedometers. These devices are small accelerometers that can be worn on a belt and/or on the ankle to record steps and Kcals during an activity. The therapist leading the intervention session will apply the ActiGraph at the beginning of each intervention session and remove it upon completion. A higher step count is a better outcome.
Observation of Time spent in age-predicted maximum high-intensity target heart rate zone
时间窗: Each session through completion of study, up to 10 days
The target range of 70-85% of age-predicted maximum heart rate will be calculated for each participant utilizing HR max = 208 - \[0.7 × age\] as developed by Tanka et al in 2001. The target range of 70-85% of age-predicted maximum heart rate will be calculated for each participant. The researchers will record the amount of time participants spend in their pre-calculated target zone during each gait training. The minimum amount of time would be 0 minutes and the maximum amount of time would be 60 minutes as this would be the total time of the session. More time spent in the maximum intensity zone target zone is a better outcome.
次要结局
- Observation of Minutes spent stepping(Each session through completion of study, up to 10 days)
- Observation of therapist Numerical Pain Rating Scale (NPRS)(Each session through completion of study, up to 10 days)
- Observation of Minutes spent in equipment setup per session(Each session through completion of study, up to 10 days)
- Observation of Minutes spent in rest breaks per session(Each session through completion of study, up to 10 days)
- Observation of Patient Borg Rating of perceived exertion (RPE)(Each session through completion of study, up to 10 days)
- Observation of therapist maximum Borg Rating of perceived exertion (RPE)(Each session through completion of study, up to 10 days)
- Observation of Patient Intrinsic Motivation Inventory (IMI)(Each session through completion of study, up to 10 days)
- Observation of therapist maximum heart rate(Each session through completion of study, up to 10 days)
研究者
Jose Pons
Principal Investigator
Shirley Ryan AbilityLab