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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04760470
Recruitment Status : Enrolling by invitation
First Posted : February 18, 2021
Last Update Posted : November 9, 2022
Sponsor:
Collaborators:
The Finnish Association of People with Physical Disabilities
Helsinki University Central Hospital
Validia Rehabilitation
Information provided by (Responsible Party):
Joonas Poutanen, University of Helsinki

Study Description
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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
Spinal Cord Injuries Other: Technological-assisted upper extremity rehabilitation Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 12, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Mean change of The Action Research Arm Test (ARAT) scores between baseline, after 6 weeks and 6 months (follow-up) [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04760470


Locations
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Finland
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
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Study Director: Sinikka Hiekkala, PhD The Finnish Association of People with Physical Disabilities
More Information
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Responsible Party: Joonas Poutanen, Principal investigator, University of Helsinki
ClinicalTrials.gov Identifier: NCT04760470    
Other Study ID Numbers: 01012021
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: November 9, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System