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

Not Applicable
Completed
Conditions
Spinal Cord Injuries
Interventions
Other: Technology-assisted upper extremity rehabilitation
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.

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
Arm && Interventions
GroupInterventionDescription
Technology-assisted upper extremity rehabilitationTechnology-assisted upper extremity rehabilitationTechnology-assisted upper extremity rehabilitation.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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 strength6 weeks,16 weeks, and 6 months

Measured with

Grip strength6 weeks,16 weeks, and 6 months

Measured with Jamar-dynamometer

Upper extremity active range of motion6 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

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