Spinal Cord InjuriesT-ARSCINCT04760470
Technology-assisted Upper Extremity Rehabilitation in Subjects with Incomplete Cervical Spinal Cord Injury
A study testing Technology-assisted upper extremity rehabilitation in people with Spinal Cord Injuries, run by University of Helsinki at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Technology-assisted upper extremity rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 12 Apr 2021to 28 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Technology-assisted upper extremity rehabilitation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-assisted upper extremity rehabilitationOther
Subjects get 6 weeks of technology-assisted upper extremity rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Technology-assisted upper extremity rehabilitation | Experimental | Technology-assisted upper extremity rehabilitation. Receives: Other: Technology-assisted upper extremity rehabilitation |
| Wait list control | No intervention | Continue their normal lives. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks or 16 weeks
Secondary outcomes (5)
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.
Measured: 6 weeks,16 weeks, and 6 months
Grip strength
Measured with Jamar-dynamometer
Measured: 6 weeks,16 weeks, and 6 months
Pinch strength
Measured with
Measured: 6 weeks,16 weeks, and 6 months
Upper extremity active range of motion
Measured with goniometer
Measured: 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.
Measured: 6 weeks,16 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start12 Apr 2021
- Primary completion28 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- The Finnish Association of People with Physical Disabilities, Helsinki University Central Hospital, Validia Rehabilitation
- Responsible party
- Principal investigator, Joonas Poutanen, University of Helsinki
- Investigators
- Sinikka Hiekkala, PhD, Study director, The Finnish Association of People with Physical Disabilities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760470
- Sponsor's protocol ID
- 01012021
- Acronym
- T-ARSCI
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2021
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-assisted Upper Extremity Rehabilitation in Subjects with Incomplete Cervical Spinal Cord Injury - Randomized Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT04760470
- Acronym / sponsor ID
- T-ARSCI / 01012021
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- The Finnish Association of People with Physical Disabilities, Helsinki University Central Hospital, Validia Rehabilitation
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology-assisted upper extremity rehabilitation | Experimental | Other: Technology-assisted upper extremity rehabilitationTechnology-assisted upper extremity rehabilitation. |
| Wait list control | No intervention | –Continue their normal lives. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-assisted upper extremity rehabilitationSubjects get 6 weeks of technology-assisted upper extremity rehabilitation | Other | Technology-assisted upper extremity rehabilitation |
Primary outcome
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.
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.
5 secondary outcomes
American Spinal Injury Association - Upper Extremity Motor Scores (ASIA-UEMS)
Time frame: 6 weeks,16 weeks, and 6 months
Grip strength
Time frame: 6 weeks,16 weeks, and 6 months
Pinch strength
Time frame: 6 weeks,16 weeks, and 6 months
Upper extremity active range of motion
Time frame: 6 weeks,16 weeks, and 6 months
Spinal Cord Independence Measure - Self Report (SCIM-SR)
Time frame: 6 weeks,16 weeks, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sinikka Hiekkala, PhD study director
The Finnish Association of People with Physical Disabilities
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-assisted upper extremity rehabilitation in people with Spinal Cord Injuries, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (ARAT) (time frame: 6 weeks,16 weeks, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.