Technology-assisted Upper Extremity Rehabilitation in Subjects with Incomplete Cervical Spinal Cord Injury (T-ARSCI)

Technology-assisted Upper Extremity Rehabilitation in Subjects with Incomplete Cervical Spinal Cord Injury - Randomized Controlled Crossover Trial

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Technology-assisted upper extremity rehabilitation

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Validia Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Wait list control; Continue their normal lives.
Experimental: Technology-assisted upper extremity rehabilitation; Technology-assisted upper extremity rehabilitation.	Other: Technology-assisted upper extremity rehabilitation; Subjects get 6 weeks of technology-assisted upper extremity rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action Research Arm Test (ARAT)	Maximum score is 114 (on a scale from 0 to 114) as the higher score indicate better upper extremity functioning.	6 weeks,16 weeks, and 6 months
Goal Attainment Scaling (GAS)	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.	6 weeks or 16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Helsinki
• Collaborators: Helsinki University Central Hospital; The Finnish Association of People with Physical Disabilities; Validia Rehabilitation
• Investigators: Study Director: Sinikka Hiekkala, PhD, The Finnish Association of People with Physical Disabilities

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): August 28, 2024
• Study Completion (Actual): August 28, 2024

Study Registration Dates

• First Submitted: February 6, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 01012021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No