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Completed

NCT Number: NCT04760470

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Validia Rehabilitation

Helsinki, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Technology-assisted upper extremity rehabilitation

Other

Subjects get 6 weeks of technology-assisted upper extremity rehabilitation

Primary outcomes

  1. Action Research Arm Test (ARAT)

    Time frame: 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.

  2. Goal Attainment Scaling (GAS)

    Time frame: 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 outcomes

  1. American Spinal Injury Association - Upper Extremity Motor Scores (ASIA-UEMS)

    Time frame: 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.

  2. Grip strength

    Time frame: 6 weeks,16 weeks, and 6 months

    Measured with Jamar-dynamometer

  3. Pinch strength

    Time frame: 6 weeks,16 weeks, and 6 months

    Measured with

  4. Upper extremity active range of motion

    Time frame: 6 weeks,16 weeks, and 6 months

    Measured with goniometer

  5. Spinal Cord Independence Measure - Self Report (SCIM-SR)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

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

Registry information

Official study title

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

Acronym: T-ARSCI

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 18, 2021
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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