Multiple Sclerosis, Chronic ProgressiveNCT03424538
The Effect of Neurorehabilitation Therapy on Postural Control, Mobility and Quality of Life in Multiple Sclerosis Patients
A study testing Neurorehabilitation and Physiotherapy in people with Multiple Sclerosis, Chronic Progressive and Multiple Sclerosis, Primary Progressive, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
Trial summary
Abstract Introduction: Postural control disorders are the most common motor disorder associated with multiple sclerosis. Objective: The aim of this study is to demonstrate the potential for improvement of postural control, motion performance and quality of life in patients with multiple sclerosis who are performing a… Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Primary Progressive
- What is being tested?
- Neurorehabilitation and Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteHungary
- Study dates
- 5 Feb 2018to 10 Jun 2018
- 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Multiple Sclerosis
- instability problem
Who cannot join
- Severe heart problems, severe demeanor, alcoholism, drug problems
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Somogy Megyei Kaposi Mór Teaching Hospital
Kaposvár, Somogy County, 7400
About this study
Official title: The Effect of Variable Intensity Work on Postural Instability, Motion Performance and Quality of Life in Multiple Sclerosis Patients
Abstract Introduction: Postural control disorders are the most common motor disorder associated with multiple sclerosis.
Objective: The aim of this study is to demonstrate the potential for improvement of postural control, motion performance and quality of life in patients with multiple sclerosis who are performing a special neurorevolutionary balancing program.
Intervention: The treated group (n = 15) performed five times a week for the treatment we defined. (60 minutes per day). The experimental group performed movements using the Xbox 360 and Kinect consoles. The study team participated in 25 sessions, five times a week. The duration of treatment was 5 weeks.The MStp group (n=14) participated in a 5-week physiotherapy course. The general treatment consisted of strengthening, stretching and walking correction. During the 5-week period, 25 patients attended training. One treatment takes 60 minutes. Sensory Organisation Test / Body Sway at the end of the baseline and treatment protocol is used to evaluate each patient. The quality of life mapping was measured by subjective tests (EQ-5D-5L, ADL). To assess the depressive state, a Beck depression questionnaire was used. Balance and motion performance were used by the Berg Balance Test and 6Minutes Walk Test. The results were compared with the control group results (n = 14) and showed improvement in overall balance and motion performance.
- Being tested
- Neurorehabilitation, Physiotherapy
- Keywords
- multiple sclerosis, posture, neurorehabilitation, balance
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurorehabilitationOther
5-week-long intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training
PhysiotherapyOther
5-week-long intervention, physiotherapy, stretching, walking preparation, strengthening
| Study group | Role | What they receive |
|---|---|---|
| MSt | Experimental | The MSt group that received 5 weeks of intensive therapy. Receives: Other: Neurorehabilitation |
| MSc | No intervention | The MS controll group that did not receive treatment. |
| MStp | Experimental | The MStp Group performs a traditional physiotherapy for 5 weeks. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural instability
Body sway (mm) (Posturography test)
Measured: 5 weeks
quality of life
EQ-5D (EQ-5D was first introduced in 1990 by the EuroQol Group, The EQ-5D questionnaire is made up for two components; health state description and evaluation)
Measured: 5 weeks
balance test
Berg Balance test (The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks, 41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk )
Measured: 5 weeks
mobility test
Six minutes walk test (6MWT) (m) (The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway)
Measured: 5 weeks
Secondary outcomes (1)
depression scale
Beck Depression scale (The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression, 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, 29-63: severe depression)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start5 Feb 2018
- Primary completion16 Apr 2018
- Study completion10 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Chronic ProgressiveStudies 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
- The single-arm, 5-week intervention is monitor every day on the effect of postural control on walking performance, balance and quality of life. The intervention team (n = 15) takes 25 training sessions for 5 weeks. Every move takes 60 minutes to continuously increase the load intensity of the X-box program. Before each intervention started, the patients perform a 10 minute warm-up and the drainage exercises are 15 minutes stretching exercises. The MStp group (n=14) participated in a 5-week physiotherapy course. The general treatment consisted of strengthening, stretching and walking correction. During the 5-week period, 25 patients attended training. One treatment takes 60 minutes. The control group (n = 14) did not receive physiotherapeutic treatment outside the medication.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen
- Responsible party
- Principal investigator, Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
- Investigators
- József Tollár, MSC, Principal investigator, Somogy Megyei Kaposi Mór Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424538
- Sponsor's protocol ID
- IKEB008/2017
- Status last verified
- Mar 2018
- First submitted
- 18 Jan 2018
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Variable Intensity Work on Postural Instability, Motion Performance and Quality of Life in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT03424538
- Acronym / sponsor ID
- IKEB008/2017
- Keywords
- multiple sclerosis, posture, neurorehabilitation, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching HospitalUniversity, hospital or other
- Collaborators
- University Medical Center Groningen
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 10 Jun 2018 (actual)
- First posted
- 7 Feb 2018 (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.
Abstract Introduction: Postural control disorders are the most common motor disorder associated with multiple sclerosis.
Objective: The aim of this study is to demonstrate the potential for improvement of postural control, motion performance and quality of life in patients with multiple sclerosis who are performing a special neurorevolutionary balancing program.
Intervention: The treated group (n = 15) performed five times a week for the treatment we defined. (60 minutes per day). The experimental group performed movements using the Xbox 360 and Kinect consoles. The study team participated in 25 sessions, five times a week. The duration of treatment was 5 weeks.The MStp group (n=14) participated in a 5-week physiotherapy course. The general treatment consisted of strengthening, stretching and walking correction. During the 5-week period, 25 patients attended training. One treatment takes 60 minutes. Sensory Organisation Test / Body Sway at the end of the baseline and treatment protocol is used to evaluate each patient. The quality of life mapping was measured by subjective tests (EQ-5D-5L, ADL). To assess the depressive state, a Beck depression questionnaire was used. Balance and motion performance were used by the Berg Balance Test and 6Minutes Walk Test. The results were compared with the control group results (n = 14) and showed improvement in overall balance and motion performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The single-arm, 5-week intervention is monitor every day on the effect of postural control on walking performance, balance and quality of life. The intervention team (n = 15) takes 25 training sessions for 5 weeks. Every move takes 60 minutes to continuously increase the load intensity of the X-box program. Before each intervention started, the patients perform a 10 minute warm-up and the drainage exercises are 15 minutes stretching exercises. The MStp group (n=14) participated in a 5-week physiotherapy course. The general treatment consisted of strengthening, stretching and walking correction. During the 5-week period, 25 patients attended training. One treatment takes 60 minutes. The control group (n = 14) did not receive physiotherapeutic treatment outside the medication.
| Arm | Type | Receives |
|---|---|---|
| MSt | Experimental | Other: NeurorehabilitationThe MSt group that received 5 weeks of intensive therapy. |
| MSc | No intervention | –The MS controll group that did not receive treatment. |
| MStp | Experimental | Other: PhysiotherapyThe MStp Group performs a traditional physiotherapy for 5 weeks. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Multiple Sclerosis
- instability problem
Key exclusion criteria (1 listed)
- Severe heart problems, severe demeanor, alcoholism, drug problems
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 |
|---|---|---|
| Neurorehabilitation5-week-long intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training | Other | MSt |
| Physiotherapy5-week-long intervention, physiotherapy, stretching, walking preparation, strengthening | Other | MStp |
Primary outcome
Postural instability
Time frame: 5 weeks
Body sway (mm) (Posturography test)
quality of life
Time frame: 5 weeks
EQ-5D (EQ-5D was first introduced in 1990 by the EuroQol Group, The EQ-5D questionnaire is made up for two components; health state description and evaluation)
balance test
Time frame: 5 weeks
Berg Balance test (The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks, 41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk )
mobility test
Time frame: 5 weeks
Six minutes walk test (6MWT) (m) (The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway)
1 secondary outcome
depression scale
Time frame: 5 weeks
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 28 Apr 2020.
- description related infoLink provided by the sponsor.
- 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.
József Tollár, MSC principal investigator
Somogy Megyei Kaposi Mór Teaching 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 Neurorehabilitation and Physiotherapy in people with Multiple Sclerosis, Chronic Progressive and Multiple Sclerosis, Primary Progressive, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
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 2 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 28 Apr 2020. 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 Hungary. 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?
Postural instability (time frame: 5 weeks). The study lists 4 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 28 Apr 2020.