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

Primary Purpose

Spinal Cord Injuries

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Technological-assisted upper extremity rehabilitation
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Validia Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Technological-assisted upper extremity rehabilitation

Wait list control

Arm Description

Technological-assisted upper extremity rehabilitation.

Continue their normal lives.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2021
Last Updated
November 7, 2022
Sponsor
University of Helsinki
Collaborators
The Finnish Association of People with Physical Disabilities, Helsinki University Central Hospital, Validia Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT04760470
Brief Title
Technological-assisted Upper Extremity Rehabilitation in Subjects With Incomplete Cervical Spinal Cord Injury
Acronym
T-ARSCI
Official Title
Technological-assisted Upper Extremity Rehabilitation in Subjects With Incomplete Cervical Spinal Cord Injury - Randomized Controlled Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki
Collaborators
The Finnish Association of People with Physical Disabilities, Helsinki University Central Hospital, Validia Rehabilitation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Technological-assisted upper extremity rehabilitation
Arm Type
Experimental
Arm Description
Technological-assisted upper extremity rehabilitation.
Arm Title
Wait list control
Arm Type
No Intervention
Arm Description
Continue their normal lives.
Intervention Type
Other
Intervention Name(s)
Technological-assisted upper extremity rehabilitation
Intervention Description
Subjects get 6 weeks of technological-assisted upper extremity rehabilitation
Primary Outcome Measure Information:
Title
Mean change of The Action Research Arm Test (ARAT) scores between baseline, after 6 weeks and 6 months (follow-up)
Description
Maximum score is 114 (on a scale from 0 to 114) as the higher score indicate better upper extremity functioning.
Time Frame
baseline, after 6 weeks and 6 months (follow-up)
Title
Mean change of Goal Attainment Scaling (GAS) scores between baseline and after 6 weeks.
Time Frame
baseline and after 6 weeks
Secondary Outcome Measure Information:
Title
Mean change of Upper Extremity Motor Scores (ASIA-UEMS) between baseline, after 6 weeks and 6 months (follow-up)
Description
Maximum score is 50 (on a scale from 0 to 50) as the higher score indicate better motor functioning in upper extremities.
Time Frame
baseline, after 6 weeks and 6 months (follow-up)
Title
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)
Title
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)
Title
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)
Title
Mean change of SCIM-SR scores between baseline, after 6 weeks and 6 months (follow-up)
Description
Maximum score is 100 (on a scale from 0 to 100) as the higher score indicate better functioning.
Time Frame
baseline, after 6 weeks and 6 months (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sinikka Hiekkala, PhD
Organizational Affiliation
The Finnish Association of People with Physical Disabilities
Official's Role
Study Director
Facility Information:
Facility Name
Validia Rehabilitation
City
Helsinki
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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