Technology-assisted Upper Extremity Rehabilitation in Subjects with Incomplete Cervical Spinal Cord Injury

Not Applicable

Completed

• Conditions: Spinal Cord Injuries

• Registration Number: NCT04760470
• Lead Sponsor: University of Helsinki

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 Timeline

• Study First Submitted: 2021-02-06
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-18
• Study Start: 2021-04-12
• Primary Completion: 2024-08-28
• Study Completion: 2024-08-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-23
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT)	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)	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 Outcome Measures

Name	Time	Method
American Spinal Injury Association - Upper Extremity Motor Scores (ASIA-UEMS)	6 weeks,16 weeks, and 6 months	Maximum score is 50 (on a scale from 0 to 50) as the higher score indicate better motor functioning in upper extremities.
Pinch strength	6 weeks,16 weeks, and 6 months	Measured with
Grip strength	6 weeks,16 weeks, and 6 months	Measured with Jamar-dynamometer
Upper extremity active range of motion	6 weeks,16 weeks, and 6 months	Measured with goniometer
Spinal Cord Independence Measure - Self Report (SCIM-SR)	6 weeks,16 weeks, and 6 months	Maximum score is 100 (on a scale from 0 to 100) as the higher score indicate better functioning.

Trial Locations

Locations (1)

Validia Rehabilitation; 🇫🇮 Helsinki, Finland