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

Sponsor
University of Helsinki (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04760470
Collaborator
The Finnish Association of People with Physical Disabilities (Other), Helsinki University Central Hospital (Other), Validia Rehabilitation (Other)
60
1
2
21.7
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Technological-assisted upper extremity rehabilitation
N/A

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
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Technological-assisted Upper Extremity Rehabilitation in Subjects With Incomplete Cervical Spinal Cord Injury - Randomized Controlled Crossover Trial
Actual Study Start Date :
Apr 12, 2021
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Technological-assisted upper extremity rehabilitation

Technological-assisted upper extremity rehabilitation.

Other: Technological-assisted upper extremity rehabilitation
Subjects get 6 weeks of technological-assisted upper extremity rehabilitation

No Intervention: Wait list control

Continue their normal lives.

Outcome Measures

Primary Outcome Measures

  1. Mean change of The Action Research Arm Test (ARAT) scores between baseline, after 6 weeks and 6 months (follow-up) [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.

  2. Mean change of Goal Attainment Scaling (GAS) scores between baseline and after 6 weeks. [baseline and after 6 weeks]

Secondary Outcome Measures

  1. Mean change of Upper Extremity Motor Scores (ASIA-UEMS) between baseline, after 6 weeks and 6 months (follow-up) [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.

  2. Mean change of Grip strength between baseline, after 6 weeks and 6 months (follow-up) [baseline, after 6 weeks and 6 months (follow-up)]

  3. Mean change of Pinch strength between baseline, after 6 weeks and 6 months (follow-up) [baseline, after 6 weeks and 6 months (follow-up)]

  4. 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)]

  5. Mean change of SCIM-SR scores between baseline, after 6 weeks and 6 months (follow-up) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Validia Rehabilitation Helsinki Finland

Sponsors and Collaborators

  • University of Helsinki
  • The Finnish Association of People with Physical Disabilities
  • Helsinki University Central Hospital
  • Validia Rehabilitation

Investigators

  • Study Director: Sinikka Hiekkala, PhD, The Finnish Association of People with Physical Disabilities

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joonas Poutanen, Principal investigator, University of Helsinki
ClinicalTrials.gov Identifier:
NCT04760470
Other Study ID Numbers:
  • 01012021
First Posted:
Feb 18, 2021
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2021