Multiple SclerosisNCT01918748
Effect of I-TRAVLE Training on Arm Function in MS and Chronic Stroke Patients
A study testing Haptic Master in people with Multiple Sclerosis and Paralytic Stroke, run by Hasselt University at 2 sites in 2 countries.
Trial summary
Rationale: Approx. 80% of acute stroke patients suffer from acute hemiparesis. Stroke patients have not reached their full potential when they are discharged from hospital. It is proven that extra training opportunities lead to further improvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Paralytic Stroke
- What is being tested?
- Haptic Master
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2013to Sep 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed with a central paresis of the arm/hand at entry in the study, caused by a supratentorial stroke;
- Post-stroke time more than 6 months (i.e. chronic phase after stroke);
- Having completed their active clinical rehabilitation program
- Hemiparesis featuring a low to moderate proximal (shoulder and arm) muscle strength:
- Motricity Index shoulder/arm item: minimum score of 14 and maximum 25 (out of 33), corresponding to a maximum active shoulder abduction of up to 90 degrees without resistance; and/or a minimum active shoulder anteflexion of 30 degrees and a maximum active range of motion of 120 degrees shoulder joint anteflexion which can actively be maintained for 10 seconds;
- a fair cognitive level, i.e. being able to understand the questionnaires and measurement instructions;
- ability to read and understand Dutch.
Who cannot join
- Severe spasticity of the arm, i.e. Modified Ashworth Scale (MAS) score for the elbow and wrist flexors: each ≥ 3;
- Severe visual impairment and/or severe cognitive impairment which may interfere with the execution of the arm-hand tasks or the measurements;
- Severe neglect in the near extra personal space (38), established by the letter cancellation test (39) and Bell's test (quantitative evaluation, (40)) with a minimum omission score of 15% (Ferber, 2001);
- Broca aphasia, Wernicke aphasia, global aphasia: as determined by the Akense Afasie Test (AAT) (41);
- Severe apraxia as measured by the apraxia test of van Heugten (42);
- no informed consent.
Trial locations and contacts
2 sites in 2 countries.
Peter Feys contact
Anneleen Maris contact
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
Revalidatie & MS Centrum Overpelt
Overpelt, Limburg, 3900
Veronique Truyens, veronik.truyens@msreva.be
Mieke Lemmens, mieke.lemmens@msreva.be
Netherlands1 site, 1 recruiting
- Recruiting
Adelante Zorggroep
Hoensbroek, 6430 AB
Henk Seelen, H.Seelen@adelante-zorggroep.nl
Sandra Stupar, s.stupar@adelante-zorggroep.nl
About this study
Official title: Effect of a Training Regime Featuring the I-TRAVLE System on Arm Function and Skill Performance in Persons With Multiple Sclerosis and Chronic Stroke Patients: a Single Arm Trial
Rationale: Approx. 80% of acute stroke patients suffer from acute hemiparesis. Stroke patients have not reached their full potential when they are discharged from hospital. It is proven that extra training opportunities lead to further improvement. To date, new training possibilities, such as robotic techniques for rehabilitation, virtual reality training systems and tele-rehabilitation are being developed to aid in the training of stroke patients.
Objective: To obtain preliminary evidence on the efficacy of an individualised, intensive 6-week technology-assisted training regime, featuring a robotics-based self-adapting arm training system (I-TRAVLE) in a virtual context, focussed on improvement of arm function and arm skill performance in chronic stroke patients with low to moderate proximal (shoulder/arm) muscle strength.
Read more
Study design: single arm prospective cohort study. Study population: 16 stroke patients in the chronic phase after their stroke, aged >=18, diagnosed with a central paresis of the arm, having low to moderate proximal (shoulder and arm) muscle strength.
Intervention (if applicable): Haptic feedback of the I-TRAVLE robot either supports or challenges the patient to perform movements of the arm, thereby training motor control and co-ordination of the affected arm. Also strength and endurance of arm muscle use may be trained. The I-TRAVLE based training will last 6 weeks. Each week participants will attend training sessions on 3 days, during which they will train 2x 30 minutes, interspaced by at least half an hour to avoid (general) fatigue and overuse.
Main study parameters/endpoints: Baseline measurements will be performed 3x prior to the start of the intervention, each interspaced by 1 week to assess baseline stability or any fluctuations in baseline values. In these chronic stroke patients spontaneous improvement is not expected. Also measurements will be performed at 0 weeks and at 12 weeks post training. Primary outcome measures: Wolf Motor Function Test, ABILHAND, and Goal Attainment Scaling. Secondary outcome measures are: motricity index, plate tapping task, active range of motion, perceived strength and fatigue.
Read the detailed description
All tests and exercises are pain free, easy to perform, non-intrusive, and not high demanding. Subjects will have to undergo an assessment via a movement protocol as well as clinical outcome tests. In both cases the type of assessment does not differ from the normal assessment at a rehabilitation centre. The training is assisted using a robotic device called the Haptic Master (HM). The participant's arm is attached to the HM via a gimbal. The HM has a number of safety features to avoid overload on the participant's arm. Any potential risk for overload is minimised by a) careful build-up of the training regime; b) regular check-ups; and c) checking the participant's status prior to the next training session.
- Conditions
- Multiple Sclerosis, Paralytic Stroke
- Being tested
- Haptic Master
- 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.
Haptic MasterDevice
Also called MOOG, Nieuw Vennep
The Haptic Master (HM) is a haptic device controlled according to the principles of 'admittance control'. In admittance control 'force' applied to the system (i.e. the HM arm) is measured, while 'position' (of the HM arm) is the end result.
| Study group | Role | What they receive |
|---|---|---|
| MS & chronic stroke patients | Experimental | Intervention: 8 weeks of I-TRAVLE based training of proximal arm function, using the haptic master.
Each week participants will attend training sessions on 5 days per 2 weeks, during which they will train 2 times 30 minutes I-TRAVLE assisted therapy, of which 1x 30 minutes supervised self-training. The two times half an hour training sessions per day will be interspaced by at least half an hour to avoid (general) fatigue and overuse of the affected arm in the subjects. Receives: Device: Haptic Master |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline Wolf Motor Function Test at 8 weeks and 3 months.
The Wolf Motor Function Test (WMFT) test contains 15 timed and 2 strength tasks (lifting the weighted limb and grip strength), ordered from simple to complex, administered sequentially to each upper extremity and controlling for patient positioning.
Measured: Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up
Secondary outcomes (4)
change from baseline motricity index at 8 weeks and 3 months
The Motricity Index (Ml) is a test that was originally constructed to clinically measure muscle strength in arm and legs of persons with neurological diseases.
Measured: Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up
change from baseline plate tapping tasks at 8 weeks and 3 months
Plate tapping tasks consist of rapid continuous aiming movements to small and large targets.
Measured: Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up
change from baseline active Range of Motion at 8 weeks and 3 months
Measured: Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up
change from baseline perceived strength & fatigue at 8 weeks and 3 months
In order to gauge the participants' perceived strength and perceived fatigue, Visual Analogue Scales are used, on which answers to two simple questions ("How strong do you feel regarding your arm muscles?" and "How fatigued do you feel at present?") are rated by the participant.
Measured: Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2014 (estimated)
- Study completionSep 2014 (estimated)
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anneleen Maris, Hasselt University
- Investigators
- Peter Feys, Doctor, Principal investigator, University Hasselt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918748
- Sponsor's protocol ID
- I-TRAVLE
- Status last verified
- Aug 2013
- First submitted
- 4 Aug 2013
- Last updated
- 8 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Training Regime Featuring the I-TRAVLE System on Arm Function and Skill Performance in Persons With Multiple Sclerosis and Chronic Stroke Patients: a Single Arm Trial
- ClinicalTrials.gov ID
- NCT01918748
- Acronym / sponsor ID
- I-TRAVLE
- Conditions
- Multiple Sclerosis, Paralytic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 8 Aug 2013 (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.
Rationale: Approx. 80% of acute stroke patients suffer from acute hemiparesis. Stroke patients have not reached their full potential when they are discharged from hospital. It is proven that extra training opportunities lead to further improvement. To date, new training possibilities, such as robotic techniques for rehabilitation, virtual reality training systems and tele-rehabilitation are being developed to aid in the training of stroke patients.
Objective: To obtain preliminary evidence on the efficacy of an individualised, intensive 6-week technology-assisted training regime, featuring a robotics-based self-adapting arm training system (I-TRAVLE) in a virtual context, focussed on improvement of arm function and arm skill performance in chronic stroke patients with low to moderate proximal (shoulder/arm) muscle strength.
Study design: single arm prospective cohort study. Study population: 16 stroke patients in the chronic phase after their stroke, aged >=18, diagnosed with a central paresis of the arm, having low to moderate proximal (shoulder and arm) muscle strength.
Intervention (if applicable): Haptic feedback of the I-TRAVLE robot either supports or challenges the patient to perform movements of the arm, thereby training motor control and co-ordination of the affected arm. Also strength and endurance of arm muscle use may be trained. The I-TRAVLE based training will last 6 weeks. Each week participants will attend training sessions on 3 days, during which they will train 2x 30 minutes, interspaced by at least half an hour to avoid (general) fatigue and overuse.
Main study parameters/endpoints: Baseline measurements will be performed 3x prior to the start of the intervention, each interspaced by 1 week to assess baseline stability or any fluctuations in baseline values. In these chronic stroke patients spontaneous improvement is not expected. Also measurements will be performed at 0 weeks and at 12 weeks post training. Primary outcome measures: Wolf Motor Function Test, ABILHAND, and Goal Attainment Scaling. Secondary outcome measures are: motricity index, plate tapping task, active range of motion, perceived strength and fatigue.
Detailed description
All tests and exercises are pain free, easy to perform, non-intrusive, and not high demanding. Subjects will have to undergo an assessment via a movement protocol as well as clinical outcome tests. In both cases the type of assessment does not differ from the normal assessment at a rehabilitation centre. The training is assisted using a robotic device called the Haptic Master (HM). The participant's arm is attached to the HM via a gimbal. The HM has a number of safety features to avoid overload on the participant's arm. Any potential risk for overload is minimised by a) careful build-up of the training regime; b) regular check-ups; and c) checking the participant's status prior to the next training session.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS & chronic stroke patients | Experimental | Device: Haptic MasterIntervention: 8 weeks of I-TRAVLE based training of proximal arm function, using the haptic master. Each week participants will attend training sessions on 5 days per 2 weeks, during which they will train 2 times 30 minutes I-TRAVLE assisted therapy, of which 1x 30 minutes supervised self-training. The two times half an hour training sessions per day will be interspaced by at least half an hour to avoid (general) fatigue and overuse of the affected arm in the subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinically diagnosed with a central paresis of the arm/hand at entry in the study, caused by a supratentorial stroke;
- Post-stroke time more than 6 months (i.e. chronic phase after stroke);
- Having completed their active clinical rehabilitation program
- Hemiparesis featuring a low to moderate proximal (shoulder and arm) muscle strength:
- Motricity Index shoulder/arm item: minimum score of 14 and maximum 25 (out of 33), corresponding to a maximum active shoulder abduction of up to 90 degrees without resistance; and/or a minimum active shoulder anteflexion of 30 degrees and a maximum active range of motion of 120 degrees shoulder joint anteflexion which can actively be maintained for 10 seconds;
Key exclusion criteria (6 listed)
- Severe spasticity of the arm, i.e. Modified Ashworth Scale (MAS) score for the elbow and wrist flexors: each ≥ 3;
- Severe visual impairment and/or severe cognitive impairment which may interfere with the execution of the arm-hand tasks or the measurements;
- Severe neglect in the near extra personal space (38), established by the letter cancellation test (39) and Bell's test (quantitative evaluation, (40)) with a minimum omission score of 15% (Ferber, 2001);
- Broca aphasia, Wernicke aphasia, global aphasia: as determined by the Akense Afasie Test (AAT) (41);
- Severe apraxia as measured by the apraxia test of van Heugten (42);
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 |
|---|---|---|
| Haptic MasterAlso: MOOG, Nieuw VennepThe Haptic Master (HM) is a haptic device controlled according to the principles of 'admittance control'. In admittance control 'force' applied to the system (i.e. the HM arm) is measured, while 'position' (of the HM arm) is the end result. | Device | MS & chronic stroke patients |
Primary outcome
change from baseline Wolf Motor Function Test at 8 weeks and 3 months.
Time frame: Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up
The Wolf Motor Function Test (WMFT) test contains 15 timed and 2 strength tasks (lifting the weighted limb and grip strength), ordered from simple to complex, administered sequentially to each upper extremity and controlling for patient positioning.
4 secondary outcomes
change from baseline motricity index at 8 weeks and 3 months
Time frame: Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up
change from baseline plate tapping tasks at 8 weeks and 3 months
Time frame: Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up
change from baseline active Range of Motion at 8 weeks and 3 months
Time frame: Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up
change from baseline perceived strength & fatigue at 8 weeks and 3 months
Time frame: Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2013.
- Website on the Individualised Technology-supported Robot-assisted Learning Environment (I-TRAVLE) systemLink provided by the sponsor.
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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.
Peter Feys contact
Anneleen Maris contact
Peter Feys, Doctor principal investigator
University Hasselt
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haptic Master in people with Multiple Sclerosis and Paralytic Stroke, run by Hasselt University at 2 sites in 2 countries.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Feys (peter.feys@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline Wolf Motor Function Test at 8 weeks and 3 months. (time frame: Pre (3x baseline) & post intervention (8 weeks), 3 month follow-up). 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 8 Aug 2013.