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

NCT ID: NCT04760470

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2024-08-28

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Technology-assisted upper extremity rehabilitation

Technology-assisted upper extremity rehabilitation.

Group Type EXPERIMENTAL

Technology-assisted upper extremity rehabilitation

Intervention Type OTHER

Subjects get 6 weeks of technology-assisted upper extremity rehabilitation

Wait list control

Continue their normal lives.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Technology-assisted upper extremity rehabilitation

Subjects get 6 weeks of technology-assisted upper extremity rehabilitation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Finnish Association of People with Physical Disabilities

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Validia Rehabilitation

UNKNOWN

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Joonas Poutanen

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sinikka Hiekkala, PhD

Role: STUDY_DIRECTOR

The Finnish Association of People with Physical Disabilities

Locations

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Validia Rehabilitation

Helsinki, , Finland

Site Status

Countries

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Finland

Other Identifiers

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01012021

Identifier Type: -

Identifier Source: org_study_id

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