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

University of Helsinki20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Spinal Cord Injuries

Interventions

Technology-assisted upper extremity rehabilitationOTHER

Subjects get 6 weeks of technology-assisted upper extremity rehabilitation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Validia Rehabilitation

Helsinki, Finland

Outcomes

Primary Outcomes

Action Research Arm Test (ARAT)

Maximum score is 114 (on a scale from 0 to 114) as the higher score indicate better upper extremity functioning.

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

Goal Attainment Scaling (GAS)

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.

Time frame: 6 weeks or 16 weeks

Secondary Outcomes

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

Maximum score is 50 (on a scale from 0 to 50) as the higher score indicate better motor functioning in upper extremities.

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

Grip strength

Measured with Jamar-dynamometer

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

Pinch strength

Measured with

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

Upper extremity active range of motion

Measured with goniometer

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

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

Maximum score is 100 (on a scale from 0 to 100) as the higher score indicate better functioning.

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

Data from ClinicalTrials.gov

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