Technological-assisted Upper Extremity Rehabilitation in Subjects With Incomplete Cervical Spinal Cord Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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Technological-assisted Upper Extremity Rehabilitation in Subjects With Incomplete Cervical Spinal Cord Injury - Randomized Controlled Crossover Trial

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: Technological-assisted upper extremity rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Technological-assisted upper extremity rehabilitation<br>Technological-assisted upper extremity rehabilitation. | Other: Technological-assisted upper extremity rehabilitation<br>* Subjects get 6 weeks of technological-assisted upper extremity rehabilitation<br>|
| No Intervention: Wait list control<br>Continue their normal lives. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of The Action Research Arm Test (ARAT) scores between baseline, after 6 weeks and 6 months (follow-up) | Maximum score is 114 (on a scale from 0 to 114) as the higher score indicate better upper extremity functioning. | baseline, after 6 weeks and 6 months (follow-up) | 
| Mean change of Goal Attainment Scaling (GAS) scores between baseline and after 6 weeks. |  | baseline and after 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of Upper Extremity Motor Scores (ASIA-UEMS) between baseline, after 6 weeks and 6 months (follow-up) | Maximum score is 50 (on a scale from 0 to 50) as the higher score indicate better motor functioning in upper extremities. | baseline, after 6 weeks and 6 months (follow-up) | 
| Mean change of Grip strength between baseline, after 6 weeks and 6 months (follow-up) |  | baseline, after 6 weeks and 6 months (follow-up) | 
| Mean change of Pinch strength between baseline, after 6 weeks and 6 months (follow-up) |  | baseline, after 6 weeks and 6 months (follow-up) | 
| Mean change of upper extremity active range of motion between baseline, after 6 weeks and 6 months (follow-up) |  | baseline, after 6 weeks and 6 months (follow-up) | 
| Mean change of SCIM-SR scores between baseline, after 6 weeks and 6 months (follow-up) | Maximum score is 100 (on a scale from 0 to 100) as the higher score indicate better functioning. | baseline, after 6 weeks and 6 months (follow-up) |