Multiple Sclerosis, Chronic ProgressiveNCT04550650
Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS Patients
A study testing Training groupe, PNF and Spinning grp 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
Different therapies can improve clinical and motor symptoms of multiple sclerosis (MS) similarly, but studies comparing the effects of different exercise therapies on clinical and motor outcomes are scant. 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?
- Training groupe, PNF and Spinning grp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteHungary
- Study dates
- 6 Apr 2018to 1 Sep 2020
- 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 Oktató Kórház
Kaposvár, Somogy County, 7400
About this study
Different therapies can improve clinical and motor symptoms of multiple sclerosis (MS) similarly, but studies comparing the effects of different exercise therapies on clinical and motor outcomes are scant. We compared the effects of exergaming (EXE), balance (BAL), cycling (CYC), proprioceptive neuromuscular facilitation (PNF), and a standard care wait-listed control group (CON) on clinical and motor symptoms and quality of life (QoL) in people with MS (PwMS).
Methods: PwMS (n = 68, 90% female; age, 47.0 yr; Expanded Disability Status Scale score 5-6) were randomized into five groups. Before and after the interventions (five times a week for 5 wk), PwMS were tested for MS-related clinical and motor symptoms (Multiple Sclerosis Impact Scale-29 (MSIS-29), primary outcome), QoL (EuroQol Five Dimensions Questionnaire), symptoms of depression, gait and balance ability (Tinetti Assessment Tool), static and dynamic balance and fall risk (Berg Balance Scale), walking capacity (6-min walk test), and standing posturography on a force platform.
Patients were followed up for 2 years after 5 weeks of intensive care. Tests are performed every six months.
- Being tested
- Training groupe, PNF, Spinning grp, Balance
- 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.
Training groupeOther
Using virtual training
PNFOther
PNF technique was used
Spinning grpOther
They only worked with spinning bikes.
BalanceOther
Balance development was done
| Study group | Role | What they receive |
|---|---|---|
| Controll | No intervention | No intervention |
| Training grp | Experimental | Neurorehabilitation 2 years long intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training Receives: Other: Training groupe |
| PNF | Experimental | 2 years long, You have only treated patients with the PNF technique. Receives: Other: PNF |
| Spinning group | Experimental | Patients developed endurance for 2 years. They worked using a spinning bike. Receives: Other: Spinning grp |
| Balance | Experimental | Neurorehabilitation 2 years long intervention, administered daily, targeted postural instability, balance Receives: Other: Balance |
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: 2 years
EQ-5D 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: 2 years
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: 2 years
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: 2 years
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: 2 years
MSIS-29
Multiple Sclerosis Questionnaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start6 Apr 2018
- Primary completion6 Apr 2020
- Study completion1 Sep 2020
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550650
- Sponsor's protocol ID
- IKEB2020/08
- Status last verified
- Mar 2022
- First submitted
- 10 Sep 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS Patients
- ClinicalTrials.gov ID
- NCT04550650
- Acronym / sponsor ID
- IKEB2020/08
- Keywords
- multiple sclerosis, posture, neurorehabilitation, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching HospitalUniversity, hospital or other
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 16 Sep 2020 (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.
Different therapies can improve clinical and motor symptoms of multiple sclerosis (MS) similarly, but studies comparing the effects of different exercise therapies on clinical and motor outcomes are scant. We compared the effects of exergaming (EXE), balance (BAL), cycling (CYC), proprioceptive neuromuscular facilitation (PNF), and a standard care wait-listed control group (CON) on clinical and motor symptoms and quality of life (QoL) in people with MS (PwMS).
Methods: PwMS (n = 68, 90% female; age, 47.0 yr; Expanded Disability Status Scale score 5-6) were randomized into five groups. Before and after the interventions (five times a week for 5 wk), PwMS were tested for MS-related clinical and motor symptoms (Multiple Sclerosis Impact Scale-29 (MSIS-29), primary outcome), QoL (EuroQol Five Dimensions Questionnaire), symptoms of depression, gait and balance ability (Tinetti Assessment Tool), static and dynamic balance and fall risk (Berg Balance Scale), walking capacity (6-min walk test), and standing posturography on a force platform.
Patients were followed up for 2 years after 5 weeks of intensive care. Tests are performed every six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Controll | No intervention | –No intervention |
| Training grp | Experimental | Other: Training groupeNeurorehabilitation 2 years long intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training |
| PNF | Experimental | Other: PNF2 years long, You have only treated patients with the PNF technique. |
| Spinning group | Experimental | Other: Spinning grpPatients developed endurance for 2 years. They worked using a spinning bike. |
| Balance | Experimental | Other: BalanceNeurorehabilitation 2 years long intervention, administered daily, targeted postural instability, balance |
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 |
|---|---|---|
| Training groupeUsing virtual training | Other | Training grp |
| PNFPNF technique was used | Other | PNF |
| Spinning grpThey only worked with spinning bikes. | Other | Spinning group |
| BalanceBalance development was done | Other | Balance |
Primary outcome
Postural instability
Time frame: 2 years
Body sway (mm) (Posturography test)
EQ-5D quality of life
Time frame: 2 years
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: 2 years
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: 2 years
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)
depression scale
Time frame: 2 years
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)
MSIS-29
Time frame: 2 years
Multiple Sclerosis Questionnaire
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 5 Apr 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis, Chronic Progressive
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis
RecruitingObservational study
REAL-MS: Observational Database Study of AHSCT and MS Therapies
Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
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 Training groupe, PNF and Spinning grp 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 5 Apr 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 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: 2 years). The study lists 6 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 5 Apr 2022.