Multiple SclerosisNCT07070388
Robotic -Assisted Rehabilitation for Multiple Sclerosis: An Adaptive Approach for Individualized Therapy
A study testing end-effector robotic training in people with Multiple Sclerosis, run by Michael Holmes at 1 site in Canada.
Trial summary
Therefore, the purpose of this study was to evaluate four-weeks of an upper limb robotic intervention for persons with Multiple Sclerosis. Participants completed a resistive and adaptive robotic training intervention whereby participants trained three times weekly for four consecutive weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- end-effector robotic training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2023to 27 Jun 2025
- 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
- Diagnosis of MS
- No other neurological diagnosis
- No injury to the upper limb (i.e., broken bones)
Who cannot join
- Relapse in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Therefore, the purpose of this study was to evaluate four-weeks of an upper limb robotic intervention for persons with Multiple Sclerosis. Participants completed a resistive and adaptive robotic training intervention whereby participants trained three times weekly for four consecutive weeks.
Read the detailed description
Nine individuals with Multiple Sclerosis participated and were placed into two groups based that either trained their self-reported less affected limb (indirect training group; N=4) or trained their self-reported more affected limb (direct training group; N=5).
- Conditions
- Multiple Sclerosis
- Being tested
- end-effector robotic training
- Keywords
- Rehabilitation, Upper Limb, Robot, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
end-effector robotic trainingDevice
For the robotic training sessions, a haptic wrist robot known as the Wristbot was used (ReWing, Genova, Italy). The training protocol consisted of an eccentric contraction-based exercise. Participants trained 3x per week for 4 consecutive weeks for approximately 25-mins per session.
| Study group | Role | What they receive |
|---|---|---|
| Indirect training group | Experimental | trained their self-reported less affected upper limb Receives: Device: end-effector robotic training |
| Direct training group | Experimental | trained their self-reported most affected limb Receives: Device: end-effector robotic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum grip force
Participants were asked to complete one trial of a maximum grip test (Baseline Evaluation Instruments). Held with a straight arm, 45° abduction by the side and hand/wrist neutral, participants were asked to squeeze the handle as hard as possible for 3 seconds and grip force (Newton) was recorded.
Measured: Baseline (Week 0) and immediately post intervention (Week 4)
Maximum isometric wrist force
the participant's arm was fully extended and rested on the table, and participants were instructed to exert force at the wrist joint (F/E, RD/UD) as hard as they could against the stationary load cell that rested on the metacarpophalangeal joints (Model: BG 500, Mark-10 Corporation, New York, USA). Two maximal exertions were completed and the largest value was recorded.
Measured: Baseline (Week 0) and immediately post intervention (Week 4)
Secondary outcomes (3)
Wrist tracking task
Participants were positioned in the same position as the training. By moving the end-effector with their wrist, participants tracked a moving icon around a Lissajous-curve. Participants were instructed to follow the icon as closely as possible. The target icon moved at a velocity of 20 °/s and 5 total laps were completed. Tracking and figural error were calculated as measures of performance.
Measured: Baseline (Week 0) and immediately post intervention (Week 4)
wrist range of motion
- Participants grasped the end-effector as target icons appeared on the monitor in front of them, participants were then asked to match the icon to the best of their abilities. When the user was at their maximal end-point range, the data was stored and recorded by the robotic device. This assessment consisted of two repetitions in each direction F/E, RD/UD.
Measured: Baseline (Week 0) and immediately post intervention (Week 4)
Wolf Motor Function Test
functional clinical assessment of the upper limb
Measured: Baseline (Week 0) and immediately post intervention (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Jan 2023
- Primary completion31 Aug 2023
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Holmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Holmes, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070388
- Sponsor's protocol ID
- Brock University
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data can be made available upon request from Open-Source Journals.
Publications
Mannella, K., Albanese, G. A., Ditor, D., Zenzeri, J. & Holmes, M. W. R. Preliminary Evaluation of an Adaptive Robotic Training Program of the Wrist for Persons with Multiple Sclerosis. Appl. Sci. 11, 9239 (2021).
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic -Assisted Rehabilitation for Multiple Sclerosis: An Adaptive Approach for Individualized Therapy
- ClinicalTrials.gov ID
- NCT07070388
- Acronym / sponsor ID
- Brock University
- Conditions
- Multiple Sclerosis
- Keywords
- Rehabilitation, Upper Limb, Robot, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Michael HolmesUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 17 Jul 2025 (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.
Therefore, the purpose of this study was to evaluate four-weeks of an upper limb robotic intervention for persons with Multiple Sclerosis. Participants completed a resistive and adaptive robotic training intervention whereby participants trained three times weekly for four consecutive weeks.
Detailed description
Nine individuals with Multiple Sclerosis participated and were placed into two groups based that either trained their self-reported less affected limb (indirect training group; N=4) or trained their self-reported more affected limb (direct training group; N=5).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indirect training group | Experimental | Device: end-effector robotic trainingtrained their self-reported less affected upper limb |
| Direct training group | Experimental | Device: end-effector robotic trainingtrained their self-reported most affected limb |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of MS
- No other neurological diagnosis
- No injury to the upper limb (i.e., broken bones)
Key exclusion criteria (1 listed)
- Relapse in the past 6 months
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 |
|---|---|---|
| end-effector robotic trainingFor the robotic training sessions, a haptic wrist robot known as the Wristbot was used (ReWing, Genova, Italy). The training protocol consisted of an eccentric contraction-based exercise. Participants trained 3x per week for 4 consecutive weeks for approximately 25-mins per session. | Device | Direct training group, Indirect training group |
Primary outcome
maximum grip force
Time frame: Baseline (Week 0) and immediately post intervention (Week 4)
Participants were asked to complete one trial of a maximum grip test (Baseline Evaluation Instruments). Held with a straight arm, 45° abduction by the side and hand/wrist neutral, participants were asked to squeeze the handle as hard as possible for 3 seconds and grip force (Newton) was recorded.
Maximum isometric wrist force
Time frame: Baseline (Week 0) and immediately post intervention (Week 4)
the participant's arm was fully extended and rested on the table, and participants were instructed to exert force at the wrist joint (F/E, RD/UD) as hard as they could against the stationary load cell that rested on the metacarpophalangeal joints (Model: BG 500, Mark-10 Corporation, New York, USA). Two maximal exertions were completed and the largest value was recorded.
3 secondary outcomes
Wrist tracking task
Time frame: Baseline (Week 0) and immediately post intervention (Week 4)
wrist range of motion
Time frame: Baseline (Week 0) and immediately post intervention (Week 4)
Wolf Motor Function Test
Time frame: Baseline (Week 0) and immediately post intervention (Week 4)
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 17 Jul 2025.
- BackgroundMannella, K., Albanese, G. A., Ditor, D., Zenzeri, J. & Holmes, M. W. R. Preliminary Evaluation of an Adaptive Robotic Training Program of the Wrist for Persons with Multiple Sclerosis. Appl. Sci. 11, 9239 (2021).
- Individual participant dataSharing planned: Yes. De-identified data can be made available upon request from Open-Source Journals.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing end-effector robotic training in people with Multiple Sclerosis, run by Michael Holmes at 1 site in Canada.
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 1 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 17 Jul 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 Canada. 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?
maximum grip force (time frame: Baseline (Week 0) and immediately post intervention (Week 4)). 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?
On the ClinicalTrials.gov record for NCT07070388, which also lists 1 linked publication.
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 17 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.