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

NCT04760470 | Completed

• 1 other identifier: 01012021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 weeks or 16 weeks

Secondary Outcomes (5)

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

  6 weeks,16 weeks, and 6 months

• Grip strength

  6 weeks,16 weeks, and 6 months

• Pinch strength

  6 weeks,16 weeks, and 6 months

• Upper extremity active range of motion

  6 weeks,16 weeks, and 6 months

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

  6 weeks,16 weeks, and 6 months

Study Arms (2)

Technology-assisted upper extremity rehabilitation

EXPERIMENTAL

Technology-assisted upper extremity rehabilitation.

Other: Technology-assisted upper extremity rehabilitation

Wait list control

NO INTERVENTION

Continue their normal lives.

Interventions

Technology-assisted upper extremity rehabilitation OTHER

Subjects get 6 weeks of technology-assisted upper extremity rehabilitation

Technology-assisted upper extremity rehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Validia Rehabilitation

Helsinki, Finland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Sinikka Hiekkala, PhD

  The Finnish Association of People with Physical Disabilities

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 18, 2021
• Study Start: April 12, 2021
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)