Technology-assisted Upper Extremity Rehabilitation in Subjects with Incomplete Cervical Spinal Cord Injury (T-ARSCI)

February 23, 2025 updated by: Joonas Poutanen, University of Helsinki

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Validia Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Wait list control
Continue their normal lives.
Experimental: Technology-assisted upper extremity rehabilitation
Technology-assisted upper extremity rehabilitation.
Other: Technology-assisted upper extremity rehabilitation
Subjects get 6 weeks of technology-assisted upper extremity rehabilitation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Action Research Arm Test (ARAT)
Time Frame: 6 weeks,16 weeks, and 6 months
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)
Time Frame: 6 weeks or 16 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
American Spinal Injury Association - Upper Extremity Motor Scores (ASIA-UEMS)
Time Frame: 6 weeks,16 weeks, and 6 months
Maximum score is 50 (on a scale from 0 to 50) as the higher score indicate better motor functioning in upper extremities.
6 weeks,16 weeks, and 6 months
Grip strength
Time Frame: 6 weeks,16 weeks, and 6 months
Measured with Jamar-dynamometer
6 weeks,16 weeks, and 6 months
Pinch strength
Time Frame: 6 weeks,16 weeks, and 6 months
Measured with
6 weeks,16 weeks, and 6 months
Upper extremity active range of motion
Time Frame: 6 weeks,16 weeks, and 6 months
Measured with goniometer
6 weeks,16 weeks, and 6 months
Spinal Cord Independence Measure - Self Report (SCIM-SR)
Time Frame: 6 weeks,16 weeks, and 6 months
Maximum score is 100 (on a scale from 0 to 100) as the higher score indicate better functioning.
6 weeks,16 weeks, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Helsinki

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Helsinki University Central Hospital
The Finnish Association of People with Physical Disabilities
Validia Rehabilitation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sinikka Hiekkala, PhD, The Finnish Association of People with Physical Disabilities

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01012021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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