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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04760470
Acronym
T-ARSCI
Enrollment
20
Registered
2021-02-18
Start date
2021-04-12
Completion date
2024-08-28
Last updated
2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

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.

Interventions

OTHERTechnology-assisted upper extremity rehabilitation

Subjects get 6 weeks of technology-assisted upper extremity rehabilitation

Sponsors

The Finnish Association of People with Physical Disabilities
CollaboratorOTHER
Helsinki University Central Hospital
CollaboratorOTHER
Validia Rehabilitation
CollaboratorUNKNOWN
University of Helsinki
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Action Research Arm Test (ARAT)6 weeks,16 weeks, and 6 monthsMaximum 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 weeksA 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

MeasureTime frameDescription
Pinch strength6 weeks,16 weeks, and 6 monthsMeasured with
American Spinal Injury Association - Upper Extremity Motor Scores (ASIA-UEMS)6 weeks,16 weeks, and 6 monthsMaximum score is 50 (on a scale from 0 to 50) as the higher score indicate better motor functioning in upper extremities.
Spinal Cord Independence Measure - Self Report (SCIM-SR)6 weeks,16 weeks, and 6 monthsMaximum score is 100 (on a scale from 0 to 100) as the higher score indicate better functioning.
Upper extremity active range of motion6 weeks,16 weeks, and 6 monthsMeasured with goniometer
Grip strength6 weeks,16 weeks, and 6 monthsMeasured with Jamar-dynamometer

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026