Technology-assisted Upper Extremity Rehabilitation in Subjects with Incomplete Cervical Spinal Cord Injury - Randomized Controlled Crossover Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Helsinki
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Action Research Arm Test (ARAT)
Study Overview
Brief Summary
The aim of the study is to investigate the effects of 6 weeks of technological-assisted rehabilitation on function of upper extremity and hand in subjects with incomplete cervical spinal cord injury.
Detailed Description
In this crossover study, persons with motor incomplete cervical (C2-C8) spinal cord injury (AIS C-D) will be recruited from the Hospital District of Helsinki and Uusimaa. In the first period of the crossover study, other part of the participants will get technological-assisted upper extremity rehabilitation, while the other part of the participants continue their normal lives. The first period is followed by 4-week wash-out period. In the second period, roles of the participants will be switched. The rehabilitation phase lasts for 6 weeks with 3 weekly sessions, each therapy session including at least 30 minutes of technological-assisted upper extremity rehabilitation. Rehabilitation includes passive, active and resistance exercises, and will be carried out by using AMADEO, PABLO and/or DIEGO devices made by Tyromotion.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •incomplete motor spinal cord injury (AIS C-D)
- •injury level C2-C8
- •time since injury from 1 to 5 years
- •to be able to sit
- •motivation and ability to participate in intensive rehabilitation 3 times per week for 6 week period.
Exclusion Criteria
- •participation in other exercise study or technological-assisted upper extremity study
- •unlikely completion of intervention and participation in follow up
- •injuries that prevent training
- •weak tolerance of intense training
- •severe joint movement restriction or instability
- •irreversible muscle contractures
- •grade 4 on Modified Ashworth Scale in glenohumeral, elbow, wrist and finger joints
- •recent significant forearm or hand injuries
- •memory disorder
- •orthopedic, rheumatic or neurological diseases (other than spinal cord injury) that prevent training
Arms & Interventions
Wait list control
Continue their normal lives.
Technology-assisted upper extremity rehabilitation
Technology-assisted upper extremity rehabilitation.
Intervention: Technology-assisted upper extremity rehabilitation (Other)
Outcomes
Primary Outcomes
Action Research Arm Test (ARAT)
Time Frame: 6 weeks,16 weeks, and 6 months
Maximum score is 114 (on a scale from 0 to 114) as the higher score indicate better upper extremity functioning.
Goal Attainment Scaling (GAS)
Time Frame: 6 weeks or 16 weeks
A method to evaluate rehabilitation effects. A 5-point scale ranging from -2 to 2. Zero represents expected level of performance after rehabilitation, +1 more than expected, and +2 much more than expected. Respectively, -1 means less than expected and -2 much less than expected.
Secondary Outcomes
- American Spinal Injury Association - Upper Extremity Motor Scores (ASIA-UEMS)(6 weeks,16 weeks, and 6 months)
- Pinch strength(6 weeks,16 weeks, and 6 months)
- Grip strength(6 weeks,16 weeks, and 6 months)
- Upper extremity active range of motion(6 weeks,16 weeks, and 6 months)
- Spinal Cord Independence Measure - Self Report (SCIM-SR)(6 weeks,16 weeks, and 6 months)
Investigators
Joonas Poutanen
Principal investigator
University of Helsinki