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

Spinal Cord Injuries Clinical Trial

— T-ARSCI  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04760470
• Other study ID #: 01012021
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: May 2023

Study information

• Verified date: November 2022
• Source: University of Helsinki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Technological-assisted upper extremity rehabilitation
Subjects get 6 weeks of technological-assisted upper extremity rehabilitation

Locations

Country	Name	City	State
Finland	Validia Rehabilitation	Helsinki

Sponsors (4)

Lead Sponsor	Collaborator
University of Helsinki	Helsinki University Central Hospital, The Finnish Association of People with Physical Disabilities, Validia Rehabilitation

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, after 6 weeks and 6 months (follow-up)
Primary	Mean change of Goal Attainment Scaling (GAS) scores between baseline and after 6 weeks.		baseline and after 6 weeks
Secondary	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.	baseline, after 6 weeks and 6 months (follow-up)
Secondary	Mean change of Grip strength between baseline, after 6 weeks and 6 months (follow-up)		baseline, after 6 weeks and 6 months (follow-up)
Secondary	Mean change of Pinch strength between baseline, after 6 weeks and 6 months (follow-up)		baseline, after 6 weeks and 6 months (follow-up)
Secondary	Mean change of upper extremity active range of motion between baseline, after 6 weeks and 6 months (follow-up)		baseline, after 6 weeks and 6 months (follow-up)
Secondary	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.	baseline, after 6 weeks and 6 months (follow-up)