Multiple SclerosisNCT05073731
Telerehabilitation-based Upper Extremity Training in People With Multiple Sclerosis
A study testing Telerehabilitation-based Upper Extremity Training in people with Multiple Sclerosis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
In this studly, the effects of an 8-week telerehabilitation-based upper extremity training in persons with multiple sclerosis will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Telerehabilitation-based Upper Extremity Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2021to 28 Oct 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a definitive diagnosis of MS according to the 2017 McDonald criteria
- Being over 18 years old
- Having answered yes to the question "Do you experience restriction in your hand-arm function and fine motor skills while performing your functional activities in daily life, and does this restriction limit your activities?"
- To have sufficient computer knowledge or to have a relative who can help in this regard to participate in the study for people with MS in the telerehabilitation group
- Having a computer and active internet connection at home for individuals with MS in the telerehabilitation group
- To be willing to participate in the study.
Who cannot join
- Having a neurological disease other than MS
- Having a relapse 30 days before or during the study
- Having an orthopedic problem that may affect the function of the upper extremity
- Cognitive disability at a level that hinders assessment and treatment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
School of Physical Therapy and Rehabilitation, Dokuz Eylül University
Izmir
Ozge Ertekin, Assoc Prof, PhD, +90 2324124941, ozge28altin@hotmail.com
Seda Dastan, BSc
About this study
Official title: Investigation of the Effects of the Synchronized Telerehabilitation-based Upper Extremity Training Program on Hand-arm Function, Pain, Fatigue, Quality of Life, and Participation in People With Multiple Sclerosis
In this studly, the effects of an 8-week telerehabilitation-based upper extremity training in persons with multiple sclerosis will be investigated.
Read the detailed description
Multiple sclerosis is a chronic, progressive, and demyelinating disease of the central nervous system that affects more than 2.5 million people worldwide and is more common in young adults. The most common clinical signs and symptoms include motor dysfunction, fatigue, spasticity, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction.
66% of people with MS have impaired upper extremity function. As a result of the deterioration in upper extremity function, the performance of many daily living activities affects performance. In conclusion, there is a decrease in the functional independence of individuals, quality of life, and participation in activities in the community.
Telerehabilitation has been defined as "the delivery of rehabilitation services through information and communication technologies." Synchronized telerehabilitation provides the participant with advantages such as customized treatment, instant feedback, and a social environment such as face-to-face training. Telerehabilitation has proven to be a valuable modality for people with MS by increasing physical activity and reducing fatigue.
In terms of telerehabilitation-based upper extremity exercise training results, the MS population is deficient. Considering the importance of bilateral hand/arm function in daily life, this deficiency in the telerehabilitation-based training effect is eliminated.
For this reason, the results of this study, which will be created for the development of upper extremity telerehabilitation strategies in MS patients, will aim to improve the hand/arm function and fine motor skills of people with MS, aiming to increase the quality of life of individuals and to participate more actively in society.
Persons who followed by the outpatient Multiple Sclerosis Clinic of Dokuz Eylül University Hospital will participate in the study. A total of 30 participants will randomly be divided into 2 groups as synchronized telerehabilitation group and asynchronous telerehabilitation group.
A physiotherapist will give physical activity training aiming to increase hand/arm function and fine motor function to the Synchronized Telerehabilitation Treatment Group via videoconference for eight weeks, two days a week, in 45-60 minute sessions. Exercise videos and exercise tracking forms will be sent to the Asynchronous Telerehabilitation Treatment Group, the control group, with the exercise intensity and intensity equalized and their progression every two weeks. Assessments will done at baseline, after 8 weeks (post-treatment) and at 8 weeks (follow-up). Assessments will be done by assessors who are blinded to the group allocation.
- Conditions
- Multiple Sclerosis
- Being tested
- Telerehabilitation-based Upper Extremity Training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation-based Upper Extremity TrainingOther
Telerehabilitation has been defined as "the delivery of rehabilitation services through information and communication technologies".
Synchronized telerehabilitation provides the participant with advantages such as customized treatment, instant feedback, and a social environment such as face-to-face training.
| Study group | Role | What they receive |
|---|---|---|
| Synchronized Telerehabilitation | Experimental | Physical activity training aiming to increase hand/arm function and fine motor function will be applied via videoconference for 8 weeks, 2 days a week, in 45-60 minute sessions. Receives: Other: Telerehabilitation-based Upper Extremity Training |
| Asynchronous Telerehabilitation | Active comparator | Exercise videos and exercise tracking form will be sent. Receives: Other: Telerehabilitation-based Upper Extremity Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine-Hole Peg Test
The Nine-Hole Peg Test measures finger dexterity.
Measured: Change from Baseline at 8 weeks
Secondary outcomes (9)
Expanded Disability Status Scale
Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Measured: Baseline
Jamar Hand Dynamometer
The Jamar Hand Dynamometer will be used to measure isometric force and peak strength.
Measured: Change from Baseline at 8 weeks
Arm Function in Multiple Sclerosis Questionnaire
Arm Function in Multiple Sclerosis Questionnaire is a unidimensional 31-item questionnaire for measuring arm function in MS. The total sum score ranged from 31 to 186 and a high score indicates a low degree of arm function.
Measured: Change from Baseline at 8 weeks
Preference-based Multiple Sclerosis Index
The Preference-based Multiple Sclerosis Index is a brief patient-reported outcome measure of health-related quality of life that consists of 5 items: walking, fatigue, mood, concentration, and roles and responsibilities. The scoring algorithm ranges from 0 (dead) to 1 (perfect health).
Measured: Change from Baseline at 8 weeks
The Modified Fatigue Impact Scale - 5
The MFIS-5 measures the impact of fatigue on cognitive, physical and psychosocial function-considered by some authors to be three important sub-scales-in patients with MS. Each item is scored between 0 and 4, and a low score indicates a low degree of fatigue.
Measured: Change from Baseline at 8 weeks
Sensewear Armband
The SenseWear Armband (SWA; Bodymedia, Pittsburgh, Pennsylvania, USA) is a lightweight metabolic monitor will be used to estimate energy expenditure.
Measured: Change from Baseline at 8 weeks
Global Perceived Effect Scale
The global perceived effect (GPE) scale is a commonly used method for measuring patients' assessment of their condition. In different studies, different questions can be modified according to different levels and response styles. In our study, we will be asked the patient, "How do you find your hand/arm function compared to pre-rehabilitation?". They will be asked to choose one of the options "much improved, a little improved, no change, a little d e t e r i o r a t i o n, or much deterioration than before rehabilitation".
Measured: At 8 weeks
Impact of Participation and Autonomy Questionnaire
The IPAQ is a questionnaire that focuses on autonomy and participation of people with chronic conditions. The participation score ranges from 0-128, and experience of problems scores ranged from 0-16, with higher scores reflecting more restrictions in participation (less community participation) and/or more experience of problems.
Measured: Change from Baseline at 8 weeks
Brief Pain Inventory-Short Form
The Brief Pain Inventory - Short Form (BPI-sf) is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning on a 10 point scale. Higher scores reflecting more pain.
Measured: Change from Baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start15 Dec 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion28 Oct 2022 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turhan Kahraman, Izmir Katip Celebi University
- Investigators
- Serkan Ozakbas, MD, Study director, MS Outpatient Clinic, Dokuz Eylul University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073731
- Sponsor's protocol ID
- 2021/23-20
- Status last verified
- May 2022
- First submitted
- 25 Sep 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of the Synchronized Telerehabilitation-based Upper Extremity Training Program on Hand-arm Function, Pain, Fatigue, Quality of Life, and Participation in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05073731
- Acronym / sponsor ID
- 2021/23-20
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 28 Oct 2022 (estimated)
- First posted
- 11 Oct 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.
In this studly, the effects of an 8-week telerehabilitation-based upper extremity training in persons with multiple sclerosis will be investigated.
Detailed description
Multiple sclerosis is a chronic, progressive, and demyelinating disease of the central nervous system that affects more than 2.5 million people worldwide and is more common in young adults. The most common clinical signs and symptoms include motor dysfunction, fatigue, spasticity, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction.
66% of people with MS have impaired upper extremity function. As a result of the deterioration in upper extremity function, the performance of many daily living activities affects performance. In conclusion, there is a decrease in the functional independence of individuals, quality of life, and participation in activities in the community.
Telerehabilitation has been defined as "the delivery of rehabilitation services through information and communication technologies." Synchronized telerehabilitation provides the participant with advantages such as customized treatment, instant feedback, and a social environment such as face-to-face training. Telerehabilitation has proven to be a valuable modality for people with MS by increasing physical activity and reducing fatigue.
In terms of telerehabilitation-based upper extremity exercise training results, the MS population is deficient. Considering the importance of bilateral hand/arm function in daily life, this deficiency in the telerehabilitation-based training effect is eliminated.
For this reason, the results of this study, which will be created for the development of upper extremity telerehabilitation strategies in MS patients, will aim to improve the hand/arm function and fine motor skills of people with MS, aiming to increase the quality of life of individuals and to participate more actively in society.
Persons who followed by the outpatient Multiple Sclerosis Clinic of Dokuz Eylül University Hospital will participate in the study. A total of 30 participants will randomly be divided into 2 groups as synchronized telerehabilitation group and asynchronous telerehabilitation group.
A physiotherapist will give physical activity training aiming to increase hand/arm function and fine motor function to the Synchronized Telerehabilitation Treatment Group via videoconference for eight weeks, two days a week, in 45-60 minute sessions. Exercise videos and exercise tracking forms will be sent to the Asynchronous Telerehabilitation Treatment Group, the control group, with the exercise intensity and intensity equalized and their progression every two weeks. Assessments will done at baseline, after 8 weeks (post-treatment) and at 8 weeks (follow-up). Assessments will be done by assessors who are blinded to the group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Synchronized Telerehabilitation | Experimental | Other: Telerehabilitation-based Upper Extremity TrainingPhysical activity training aiming to increase hand/arm function and fine motor function will be applied via videoconference for 8 weeks, 2 days a week, in 45-60 minute sessions. |
| Asynchronous Telerehabilitation | Active comparator | Other: Telerehabilitation-based Upper Extremity TrainingExercise videos and exercise tracking form will be sent. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having a definitive diagnosis of MS according to the 2017 McDonald criteria
- Being over 18 years old
- Having answered yes to the question "Do you experience restriction in your hand-arm function and fine motor skills while performing your functional activities in daily life, and does this restriction limit your activities?"
- To have sufficient computer knowledge or to have a relative who can help in this regard to participate in the study for people with MS in the telerehabilitation group
- Having a computer and active internet connection at home for individuals with MS in the telerehabilitation group
Key exclusion criteria (4 listed)
- Having a neurological disease other than MS
- Having a relapse 30 days before or during the study
- Having an orthopedic problem that may affect the function of the upper extremity
- Cognitive disability at a level that hinders assessment and treatment.
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 |
|---|---|---|
| Telerehabilitation-based Upper Extremity TrainingTelerehabilitation has been defined as "the delivery of rehabilitation services through information and communication technologies". Synchronized telerehabilitation provides the participant with advantages such as customized treatment, instant feedback, and a social environment such as face-to-face training. | Other | Asynchronous Telerehabilitation, Synchronized Telerehabilitation |
Primary outcome
Nine-Hole Peg Test
Time frame: Change from Baseline at 8 weeks
The Nine-Hole Peg Test measures finger dexterity.
9 secondary outcomes
Expanded Disability Status Scale
Time frame: Baseline
Jamar Hand Dynamometer
Time frame: Change from Baseline at 8 weeks
Arm Function in Multiple Sclerosis Questionnaire
Time frame: Change from Baseline at 8 weeks
Preference-based Multiple Sclerosis Index
Time frame: Change from Baseline at 8 weeks
The Modified Fatigue Impact Scale - 5
Time frame: Change from Baseline at 8 weeks
Sensewear Armband
Time frame: Change from Baseline at 8 weeks
Global Perceived Effect Scale
Time frame: At 8 weeks
Impact of Participation and Autonomy Questionnaire
Time frame: Change from Baseline at 8 weeks
Brief Pain Inventory-Short Form
Time frame: Change from Baseline at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- 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.
Serkan Ozakbas, MD study director
MS Outpatient Clinic, Dokuz Eylul University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation-based Upper Extremity Training in people with Multiple Sclerosis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 6 inclusion and 4 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 1 Jun 2022. 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 Turkey (Türkiye). 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 Turhan Kahraman, PhD (+905557219849, turhan.kahraman@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nine-Hole Peg Test (time frame: Change from Baseline at 8 weeks). 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 1 Jun 2022.