Multiple SclerosisPhase 1TelerehabNCT02764372
Telerehabilitation Upper Extremity for Neurological Disorders
A Phase 1 study testing Serious games and Exergames in people with Multiple Sclerosis and Stroke, run by Fondazione Don Carlo Gnocchi ETS.
Trial summary
The aims of the present study were to: Investigate the feasibility of using a therapeutic gaming system (REHAB@HOME), based on Kinect, to augment upper extremity neurorehabilitation services. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multiple Sclerosis, Stroke
- What is being tested?
- Serious games and Exergames
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Apr 2016
- Phase
- Phase 1
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons Post stroke or with MS with resultant upper extremity motor deficits.
- Range of motion of shoulder and elbow equal or higher than 45 degrees.
- Able to comprehend and follow directions.
Who cannot join
- Wearing pace maker
- Comorbidities affecting arm use
- Not able to comprehend and follow directions
About this study
Official title: Serious Games for Upper Extremity Rehabilitation for Patients With Neurological Disorders: A Pilot Study
The aims of the present study were to:
- Investigate the feasibility of using a therapeutic gaming system (REHAB@HOME), based on Kinect, to augment upper extremity neurorehabilitation services.
- Provide preliminary evidence of clinical efficacy of the approach in increasing arm activity and health related quality of life of persons post stroke or with MS.
Main results suggest that the serious games approach was positively received in terms of user experience and motivation to use, with the participants showing also improvements in functional abilities of the treated arm.
Read the detailed description
The objective of this pilot study was to assess the feasibility of using a therapeutic gaming system (REHAB@HOME), based on Kinect, to augment upper extremity neurorehabilitation services. A secondary objective was to provide preliminary evidence of clinical efficacy of the approach in increasing arm activity and health related quality of life of persons post stroke or with multiple sclerosis (MS).
A pilot single-blind randomized controlled trial was carried out in an inpatient and ambulatory care at a rehabilitation center. Twenty persons with multiple sclerosis (n=16) or chronic poststroke (n=4) receiving rehabilitation at the center, able to flex shoulder and elbow at least 45 degrees, participated in the study.
An intervention group received Serious Games-based upper extremity therapy for a total of 12 sessions (4-5 sessions, lasting 40 minutes, per week) and the control played the same amount of time with commercial exergames of the Wii. Both groups received their usual rehabilitation services as well as game playing.
- Conditions
- Multiple Sclerosis, Stroke
- Being tested
- Serious games, Exergames
- Keywords
- Arm rehabilitation, Serious games, stroke, Multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious gamesBehavioural
Also called virtual reality games
Participants played serious games developed for Kinect in the the EU FP7 STREP Project REHAB@HOME N. 306113
ExergamesBehavioural
Also called Wii game console
Participants played exergames existent in the Wii game console
| Study group | Role | What they receive |
|---|---|---|
| Serious games | Experimental | The experimental group received Serious Games-based upper extremity therapy through Kinect Receives: Behavioral: Serious games |
| Exergames | Active comparator | The control played the same amount of time with commercial exergames of the Wii Receives: Behavioral: Exergames |
What is being measured
The primary outcome is the main question the study is designed to answer.
9 Hole peg test
Testing pre and post intervention
Measured: 10 months
Box and Block test
Testing pre and post intervention
Measured: 10 months
Secondary outcomes (2)
Short Form 12
Testing pre and post intervention
Measured: 10 months
the EQ-5D visual analogue scale (EQ-VAS)
Testing pre and post intervention
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bremen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764372
- Sponsor's protocol ID
- Rehab2016
- Acronym
- Telerehab
- Status last verified
- May 2016
- First submitted
- 3 May 2016
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serious Games for Upper Extremity Rehabilitation for Patients With Neurological Disorders: A Pilot Study
- ClinicalTrials.gov ID
- NCT02764372
- Acronym / sponsor ID
- Telerehab / Rehab2016
- Conditions
- Multiple Sclerosis, Stroke
- Keywords
- Arm rehabilitation, Serious games, stroke, Multiple sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- University of Bremen
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 6 May 2016 (estimated)
- 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 aims of the present study were to:
- Investigate the feasibility of using a therapeutic gaming system (REHAB@HOME), based on Kinect, to augment upper extremity neurorehabilitation services.
- Provide preliminary evidence of clinical efficacy of the approach in increasing arm activity and health related quality of life of persons post stroke or with MS.
Main results suggest that the serious games approach was positively received in terms of user experience and motivation to use, with the participants showing also improvements in functional abilities of the treated arm.
Detailed description
The objective of this pilot study was to assess the feasibility of using a therapeutic gaming system (REHAB@HOME), based on Kinect, to augment upper extremity neurorehabilitation services. A secondary objective was to provide preliminary evidence of clinical efficacy of the approach in increasing arm activity and health related quality of life of persons post stroke or with multiple sclerosis (MS).
A pilot single-blind randomized controlled trial was carried out in an inpatient and ambulatory care at a rehabilitation center. Twenty persons with multiple sclerosis (n=16) or chronic poststroke (n=4) receiving rehabilitation at the center, able to flex shoulder and elbow at least 45 degrees, participated in the study.
An intervention group received Serious Games-based upper extremity therapy for a total of 12 sessions (4-5 sessions, lasting 40 minutes, per week) and the control played the same amount of time with commercial exergames of the Wii. Both groups received their usual rehabilitation services as well as game playing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serious games | Experimental | Behavioral: Serious gamesThe experimental group received Serious Games-based upper extremity therapy through Kinect |
| Exergames | Active comparator | Behavioral: ExergamesThe control played the same amount of time with commercial exergames of the Wii |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persons Post stroke or with MS with resultant upper extremity motor deficits.
- Range of motion of shoulder and elbow equal or higher than 45 degrees.
- Able to comprehend and follow directions.
Key exclusion criteria (3 listed)
- Wearing pace maker
- Comorbidities affecting arm use
- Not able to comprehend and follow directions
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 |
|---|---|---|
| Serious gamesAlso: virtual reality gamesParticipants played serious games developed for Kinect in the the EU FP7 STREP Project REHAB@HOME N. 306113 | Behavioural | Serious games |
| ExergamesAlso: Wii game consoleParticipants played exergames existent in the Wii game console | Behavioural | Exergames |
Primary outcome
9 Hole peg test
Time frame: 10 months
Testing pre and post intervention
Box and Block test
Time frame: 10 months
Testing pre and post intervention
2 secondary outcomes
Short Form 12
Time frame: 10 months
the EQ-5D visual analogue scale (EQ-VAS)
Time frame: 10 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 6 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Serious games and Exergames in people with Multiple Sclerosis and Stroke, run by Fondazione Don Carlo Gnocchi ETS.
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 3 inclusion and 3 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 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
9 Hole peg test (time frame: 10 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 6 May 2016; AzTrials last refreshed its copy on 6 Nov 2026.