Clinical trial NCT04760470: Technology-assisted Upper Extremity Rehabilitation in Subjects with Incomplete Cervical Spinal Cord Injury
Official title: Technology-assisted Upper Extremity Rehabilitation in Subjects with Incomplete Cervical Spinal Cord Injury - Randomized Controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: The Finnish Association of People with Physical Disabilities
name: Helsinki University Central Hospital
name: Validia Rehabilitation
First posted: 2021-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: 6 weeks,16 weeks, and 6 months
measure: Goal Attainment Scaling (GAS)
timeFrame: 6 weeks or 16 weeks
Secondary outcomes:
measure: American Spinal Injury Association - Upper Extremity Motor Scores (ASIA-UEMS)
timeFrame: 6 weeks,16 weeks, and 6 months
measure: Grip strength
timeFrame: 6 weeks,16 weeks, and 6 months
measure: Pinch strength
timeFrame: 6 weeks,16 weeks, and 6 months
measure: Upper extremity active range of motion
timeFrame: 6 weeks,16 weeks, and 6 months
measure: Spinal Cord Independence Measure - Self Report (SCIM-SR)
timeFrame: 6 weeks,16 weeks, and 6 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Validia Rehabilitation
Study officials:
affiliation: The Finnish Association of People with Physical Disabilities
name: Sinikka Hiekkala, PhD
role: STUDY_DIRECTOR
References: