Multiple SclerosisTEAMSNCT04032431
Upper Limb Telerehabilitation With Virtual Reality in Multiple Sclerosis
A study testing Telerehab VR intervention in people with Multiple Sclerosis, run by University of Cagliari at 2 sites in 2 countries.
Trial summary
This study aims to investigate the effectiveness of a home-based telerehabilitation program specifically designed for upper limbs, based on Virtual Reality (VR) in individuals affected by Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Telerehab VR intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2020to 1 Sep 2022
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of MS according to the revised McDonald Criteria 2017;
- aged 25-60 years old;
- an Expanded Disability Status Scale score ≥6;
- an ability to understand and execute simple instructions;
- a cut-off score of >0.5 pegs/s(=18s) on the NHPT (selected due to its high discriminative and predictive ability in distinguishing ADL independence in pwMS).
Who cannot join
- orthopedic and other neurological disorders affecting upper limb movements (e.g., epileptic seizures);
- contra-indication to physical activity (e.g., heart failure, severe osteoporosis);
- moderate or severe cognitive impairments as indicated by the Mini-Mental State Examination score <21;
- pregnancy (self-reported);
- severe uncorrected visual deficits;
- MS clinical relapse or treatment with corticosteroid therapy within 90 days prior to enrollment;
Show all 9Show fewer
- started or stopped a disease-modifying therapy for MS within 90 days prior to enrollment;
- patients who received a course of physical or occupational therapy (home, outpatient or inpatient) within the past 30 days;
- other treatments that could influence the effects of the interventions
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Israel1 site
The Multiple Sclerosis Center, Sheba Medical Center
Tel HaShomer
Alon Kalron, PhD
+972-3-6405430, alkalron@gmail.com
Italy1 site
Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di Cagliari
Monserrato, Cagliari, 09042
About this study
Official title: The Effect of a Telerehabilitation Virtual Reality Intervention on Functional Upper Limb Activities in People With Multiple Sclerosis
This study aims to investigate the effectiveness of a home-based telerehabilitation program specifically designed for upper limbs, based on Virtual Reality (VR) in individuals affected by Multiple Sclerosis.
Read the detailed description
Approximately 60% of people with multiple sclerosis (pwMS) suffer from upper limb dysfunction. The primary goal of this study is to implement a single-blind, randomized control trial (RCT) designed to compare the effectiveness of an 8-week home-based telerehab virtual reality (VR) program with conventional therapy in pwMS with manual dexterity difficulties. Secondary aims include; a) evaluating the impact of the programs on quality of life after the intervention and a follow up 1 month later; and b) evaluating the impact of the programs on adherence and satisfaction.
Methodology. Twenty-four pwMS will be recruited to participate in the study which will be conducted at two established MS Centers: (1) The Sardinian Center for Diagnosis and Treatment of Multiple Sclerosis, Binaghi Hospital, Cagliari, Italy; (2) The Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel. Participants will complete a total of three assessments focusing on upper limb functions. Both groups will receive 16 training sessions focusing on functional upper limb activities. The home-based telerehab VR intervention will comprise a custom-made software program running on a private computer or laptop. pwMS will perform several activities of daily living (ADL) functions associated with self-care, dressing and meal preparation.
Conventional therapy will focus on task-related upper-limb treatments while in a sitting or prone position, indicative of the standard care in multiple sclerosis (MS). Following 8-weeks of training, participants will complete a further outcome assessment. The same tests will be conducted 1 month (as a follow-up) after completion of the intervention.
Potential scientific contribution. The outcomes of this study have tremendous potential to improve the quality of evidence and informed decisions of functional upper limb activities in pwMS. If comparable results are found between the treatments in improving upper limb outcomes, this would suggest that pwMS can choose the program that best meets their personal needs, e.g., financial concerns, transportation or accessibility issues. Secondly, this information can be used by healthcare providers and medical professionals in developing upper limb exercise programs that will most likely succeed in pwMS and will then be disseminated to neurologists and other medical providers.
Mode of cooperation and added value. The Italian group will be responsible for designing and implementing three new VR scenarios relating to functional activities of the upper limb. The new VR scenarios will be planned in conjunction with the Israeli group who will also play an active role in the quality assessment procedures of the developed elements. Both groups will participate equally in the pilot RCT. Roles include: recruitment and guidance of patients and therapists, implementing the telerehab VR system in the patient's home, assessment of outcome measures, data collection, analysis and interpretation of data and dissemination of the findings. An additional role of the Israeli team will be to prepare a user manual detailing how to use the system and providing clinical guidelines/recommendations for both the therapist and patient.
- Conditions
- Multiple Sclerosis
- Being tested
- Telerehab VR intervention
- Keywords
- Rehabilitation, Virtual Reality, Upper limb, Neurorehabilitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehab VR interventionBehavioural
Training with VR system using software specifically designed to reproduce activities of daily living
| Study group | Role | What they receive |
|---|---|---|
| Telerehab VR intervention | Experimental | The telerehab VR intervention consists of a custom-made software running on a computer connected with a commercial VR device (i.e. Oculus Rift). PwMS will be requested to reproduce several ADLs from the three main areas of self-care, dressing and meal preparation. The user can physically see his/her hands within the virtual scenario and, during the exercise, the hand coordinates are continuously recorded. Thus, data on 3D trajectory, speed, accuracy on target placement and movement smoothness, will be accessible. They will be stored in the PC and also be remotely sent to the clinical center for further analysis/processing. Both target position and task complexity will define the exercise difficulty, which can be modified automatically, on the basis of the previous performance or manually modified by the user Receives: Behavioral: Telerehab VR intervention |
| Conventional therapy | Active comparator | Conventional therapy will focus on task-related upper-limb treatments while in a sitting or prone position, representing the standard care in MS. Several manual techniques, therapy tools and objects of ADL will be allowed during treatment. No restrictions will be placed on the material used (ie, ADL, reaching and grasping material). Use of additional electrical or mechanical therapy devices (ie, support arm systems, splints) will be avoided. The interventions will be conducted on a one-on-one basis in the physiotherapy or occupational therapy department of each participating center. Training and therapy content will be tailored to each participant's preferences, the agreed movement aims and the motor function level of each MS patient. Receives: Behavioral: Telerehab VR intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nine Hole Peg Test (9HPT)
The NHPT was selected based on the widespread adoption and extensive data available. Furthermore, the NHPT is recommended as a gold standard for measuring manual dexterity in pwMS.31 The NHPT has excellent psychometric properties regarding reliability, discriminant, concurrent and ecological validity, can detect progression over time, is sensitive to treatment and as such, is recommended for inclusion in clinical trials. Briefly explained, the NHPT requires participants to repeatedly place nine pegs into nine holes, one at a time, as quickly as possible and then remove them from the holes. The total time needed to complete the task is then recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand.
Measured: Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline)
Secondary outcomes (3)
Action Research Arm Test (ARAT)
The ARAT is a 19 item observational measure used by physical therapists and healthcare professionals to assess upper extremity performance in terms of coordination, dexterity and functioning in several neurologic conditions, including MS.32 Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).
Measured: Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline), 1 month follow-up (T2, +12 weeks from baseline)
Manual Ability Measure-36 (MAM-36)
The MAM-36 is a questionnaire based on perceived ease or difficulty that a person may experience when performing unilateral and bilateral ADL tasks. During a semi-structured interview, the subject is asked to rate 36 unilateral and bilateral ADL tasks using a 4-point scale. The score of the different tasks are summed up and transformed using a Rasch-derived conversion table. The MAM-36 has adequate psychometric properties and is recommended as an outcome measure for upper limb function in pwMS
Measured: Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline), 1 month follow-up (T2, +12 weeks from baseline)
Value of "Impression of change" parameter
A 7-point Likert-type global rating scale from both the patient and therapist's perspective will be applied. The question that will be asked will be: "Compared to before treatment, at present, how would you rate your/the participant's functional upper limb activities?" The responses will be rated as: 1= worse than ever, 2 = much worse, 3 = slightly worse, 4 = unchanged, 5 = slightly improved, 6 = much improved, 7= greatly improved.
Measured: Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline), 1 month follow-up (T2, +12 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start1 Dec 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
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
- Model description
- This is a prospective, assessor blinded, parallel group pilot RCT that will be conducted at: 1. The Sardinian Center for Diagnosis and Treatment of Multiple Sclerosis, Cagliari, Italy. 2. The Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel. Participants will be randomly assigned to one of the two intervention groups: 1. Telerehab VR training; 2. Conventional therapy The two interventions will be comparable in length (8-weeks), frequency (twice weekly) and session duration (50-60 min). Pre-intervention tests (T0) characterizing groups and obtaining baseline values of primary and secondary outcome measures will be performed one week±3 days prior to the intervention program. Within one week after completion of the intervention, post-intervention tests will be performed (T1). The same tests will be repeated after 1-month of follow-up (T2). During the follow-up period (T1-T2), patients will be instructed to continue their regular activities.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Sanitaria Locale di Cagliari, Tel Aviv University
- Responsible party
- Principal investigator, Massimiliano Pau, University of Cagliari
- Investigators
- Eleonora Cocco, PhD, Principal investigator, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032431
- Sponsor's protocol ID
- Italy-Israel-2019
- Acronym
- TEAMS
- Status last verified
- Mar 2020
- First submitted
- 17 Jul 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalron A, Achiron A, Pau M, Cocco E. The effect of a telerehabilitation virtual reality intervention on functional upper limb activities in people with multiple sclerosis: a study protocol for the TEAMS pilot randomized controlled trial. Trials. 2020 Aug 12;21(1):713. doi: 10.1186/s13063-020-04650-2.
PubMed 32787896
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Telerehabilitation Virtual Reality Intervention on Functional Upper Limb Activities in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04032431
- Acronym / sponsor ID
- TEAMS / Italy-Israel-2019
- Conditions
- Multiple Sclerosis
- Keywords
- Rehabilitation, Virtual Reality, Upper limb, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Collaborators
- Azienda Sanitaria Locale di Cagliari, Tel Aviv University
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 25 Jul 2019 (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.
This study aims to investigate the effectiveness of a home-based telerehabilitation program specifically designed for upper limbs, based on Virtual Reality (VR) in individuals affected by Multiple Sclerosis.
Detailed description
Approximately 60% of people with multiple sclerosis (pwMS) suffer from upper limb dysfunction. The primary goal of this study is to implement a single-blind, randomized control trial (RCT) designed to compare the effectiveness of an 8-week home-based telerehab virtual reality (VR) program with conventional therapy in pwMS with manual dexterity difficulties. Secondary aims include; a) evaluating the impact of the programs on quality of life after the intervention and a follow up 1 month later; and b) evaluating the impact of the programs on adherence and satisfaction.
Methodology. Twenty-four pwMS will be recruited to participate in the study which will be conducted at two established MS Centers: (1) The Sardinian Center for Diagnosis and Treatment of Multiple Sclerosis, Binaghi Hospital, Cagliari, Italy; (2) The Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel. Participants will complete a total of three assessments focusing on upper limb functions. Both groups will receive 16 training sessions focusing on functional upper limb activities. The home-based telerehab VR intervention will comprise a custom-made software program running on a private computer or laptop. pwMS will perform several activities of daily living (ADL) functions associated with self-care, dressing and meal preparation.
Conventional therapy will focus on task-related upper-limb treatments while in a sitting or prone position, indicative of the standard care in multiple sclerosis (MS). Following 8-weeks of training, participants will complete a further outcome assessment. The same tests will be conducted 1 month (as a follow-up) after completion of the intervention.
Potential scientific contribution. The outcomes of this study have tremendous potential to improve the quality of evidence and informed decisions of functional upper limb activities in pwMS. If comparable results are found between the treatments in improving upper limb outcomes, this would suggest that pwMS can choose the program that best meets their personal needs, e.g., financial concerns, transportation or accessibility issues. Secondly, this information can be used by healthcare providers and medical professionals in developing upper limb exercise programs that will most likely succeed in pwMS and will then be disseminated to neurologists and other medical providers.
Mode of cooperation and added value. The Italian group will be responsible for designing and implementing three new VR scenarios relating to functional activities of the upper limb. The new VR scenarios will be planned in conjunction with the Israeli group who will also play an active role in the quality assessment procedures of the developed elements. Both groups will participate equally in the pilot RCT. Roles include: recruitment and guidance of patients and therapists, implementing the telerehab VR system in the patient's home, assessment of outcome measures, data collection, analysis and interpretation of data and dissemination of the findings. An additional role of the Israeli team will be to prepare a user manual detailing how to use the system and providing clinical guidelines/recommendations for both the therapist and patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, assessor blinded, parallel group pilot RCT that will be conducted at: 1. The Sardinian Center for Diagnosis and Treatment of Multiple Sclerosis, Cagliari, Italy. 2. The Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel. Participants will be randomly assigned to one of the two intervention groups: 1. Telerehab VR training; 2. Conventional therapy The two interventions will be comparable in length (8-weeks), frequency (twice weekly) and session duration (50-60 min). Pre-intervention tests (T0) characterizing groups and obtaining baseline values of primary and secondary outcome measures will be performed one week±3 days prior to the intervention program. Within one week after completion of the intervention, post-intervention tests will be performed (T1). The same tests will be repeated after 1-month of follow-up (T2). During the follow-up period (T1-T2), patients will be instructed to continue their regular activities.
| Arm | Type | Receives |
|---|---|---|
| Telerehab VR intervention | Experimental | Behavioral: Telerehab VR interventionThe telerehab VR intervention consists of a custom-made software running on a computer connected with a commercial VR device (i.e. Oculus Rift). PwMS will be requested to reproduce several ADLs from the three main areas of self-care, dressing and meal preparation. The user can physically see his/her hands within the virtual scenario and, during the exercise, the hand coordinates are continuously recorded. Thus, data on 3D trajectory, speed, accuracy on target placement and movement smoothness, will be accessible. They will be stored in the PC and also be remotely sent to the clinical center for further analysis/processing. Both target position and task complexity will define the exercise difficulty, which can be modified automatically, on the basis of the previous performance or manually modified by the user |
| Conventional therapy | Active comparator | Behavioral: Telerehab VR interventionConventional therapy will focus on task-related upper-limb treatments while in a sitting or prone position, representing the standard care in MS. Several manual techniques, therapy tools and objects of ADL will be allowed during treatment. No restrictions will be placed on the material used (ie, ADL, reaching and grasping material). Use of additional electrical or mechanical therapy devices (ie, support arm systems, splints) will be avoided. The interventions will be conducted on a one-on-one basis in the physiotherapy or occupational therapy department of each participating center. Training and therapy content will be tailored to each participant's preferences, the agreed movement aims and the motor function level of each MS patient. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosis of MS according to the revised McDonald Criteria 2017;
- aged 25-60 years old;
- an Expanded Disability Status Scale score ≥6;
- an ability to understand and execute simple instructions;
- a cut-off score of >0.5 pegs/s(=18s) on the NHPT (selected due to its high discriminative and predictive ability in distinguishing ADL independence in pwMS).
Key exclusion criteria (9 listed)
- orthopedic and other neurological disorders affecting upper limb movements (e.g., epileptic seizures);
- contra-indication to physical activity (e.g., heart failure, severe osteoporosis);
- moderate or severe cognitive impairments as indicated by the Mini-Mental State Examination score <21;
- pregnancy (self-reported);
- severe uncorrected visual deficits;
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 |
|---|---|---|
| Telerehab VR interventionTraining with VR system using software specifically designed to reproduce activities of daily living | Behavioural | Conventional therapy, Telerehab VR intervention |
Primary outcome
Change in Nine Hole Peg Test (9HPT)
Time frame: Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline)
The NHPT was selected based on the widespread adoption and extensive data available. Furthermore, the NHPT is recommended as a gold standard for measuring manual dexterity in pwMS.31 The NHPT has excellent psychometric properties regarding reliability, discriminant, concurrent and ecological validity, can detect progression over time, is sensitive to treatment and as such, is recommended for inclusion in clinical trials. Briefly explained, the NHPT requires participants to repeatedly place nine pegs into nine holes, one at a time, as quickly as possible and then remove them from the holes. The total time needed to complete the task is then recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand.
3 secondary outcomes
Action Research Arm Test (ARAT)
Time frame: Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline), 1 month follow-up (T2, +12 weeks from baseline)
Manual Ability Measure-36 (MAM-36)
Time frame: Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline), 1 month follow-up (T2, +12 weeks from baseline)
Value of "Impression of change" parameter
Time frame: Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline), 1 month follow-up (T2, +12 weeks from baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 32787896Kalron A, Achiron A, Pau M, Cocco E. The effect of a telerehabilitation virtual reality intervention on functional upper limb activities in people with multiple sclerosis: a study protocol for the TEAMS pilot randomized controlled trial. Trials. 2020 Aug 12;21(1):713. doi: 10.1186/s13063-020-04650-2.
- 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.
Eleonora Cocco, PhD principal investigator
University of Cagliari
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehab VR intervention in people with Multiple Sclerosis, run by University of Cagliari 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 5 inclusion and 9 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 24 Mar 2020. 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 Israel, Italy. 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 Massimiliano Pau, PhD (+390706753264, massimiliano.pau@dimcm.unica.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nine Hole Peg Test (9HPT) (time frame: Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline)). 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 NCT04032431, 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 24 Mar 2020.