Multiple SclerosisNCT04132167
Supervised Perturbation Training Results in Changes in Balance and Falling in Patients With Multiple Sclerosis
A study testing perturbation training in people with Multiple Sclerosis, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
Physical exercise can prevent falls, certain types of exercise may be more effective. Perturbation-based balance training is a novel intervention involving repeated postural perturbations aiming to improve control of rapid balance reactions. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- perturbation training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2018to 20 Dec 2019
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- An age older than 18 years
- Stable phase of the disease without relapses or worsening in the last three months
- Referring fear of falling or a history of falls (at least one fall in the last year).
- Individuals with a high level of balance.
Who cannot join
- Psychiatric disorders
- Blurred vision
- Severe cognitive impairment
- Severely impaired upright postural control or limited participation in a rehabilitation program
- Cardiovascular and respiratory disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Physical exercise can prevent falls, certain types of exercise may be more effective. Perturbation-based balance training is a novel intervention involving repeated postural perturbations aiming to improve control of rapid balance reactions. The purpose of this study was to estimate the effect of perturbation- based balance training on falls and balance in daily life.Thirty patients with multiple sclerosis (PwMS) will assess with regard to dynamic balance, walking and falling. Patients randomly will allocate to a personalized (PRG) or traditional (TRG) rehabilitation group.
Read the detailed description
Thirty patients with multiple sclerosis (PwMS) will assess with regard to dynamic balance, walking and falling. Patients randomly will allocate to a personalized (PRG) or traditional (TRG) rehabilitation group.
- Conditions
- Multiple Sclerosis
- Being tested
- perturbation training
- Keywords
- Rehabilitation, Multiple sclerosis, Tailored interventions
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perturbation trainingProcedure or surgery
exercises for body stability in different positions (bridge, sitting, quadrupedal, half- kneeling, kneeling, standing, monopodalic) performed with visual biofeedback; transfers training performed in front of a mirror; ambulation training with courses drawn on the ground in a straight line and with more complex tracks with visual controlin particular using the protocols seated balance/strength training, standing bal- ance/weight-bearing training, mobility training and closed-chain training;
| Study group | Role | What they receive |
|---|---|---|
| training group | Experimental | perturbation balance training Receives: Procedure: perturbation training |
| control group | Active comparator | traditional physical therapy that including strengthening and stretching Receives: Procedure: perturbation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
dynamic balance
the effects of perturbation dynamic balance training assessed with four square step test >15 seconds = increased risk of falls
Measured: 6 week
walking
the effects of perturbation dynamic balance training assessed with 10 meter walking test
Measured: 6 week
walking
the effects of perturbation dynamic balance training assessed with time up and go test(TUG).A score of 30 seconds or more suggests that the person may be prone to falls
Measured: 6 week
falling
the effects of perturbation dynamic balance training assessed with Falling Efficacy Scale(FES). The FES is a 10-item test. On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all.
Measured: 6 week
fear of falling
The short FES-I is a 7-item self-report questionnaire for measuring perceived self-efficacy to avoid a fall in various situations
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start20 Nov 2018
- Primary completion20 Oct 2019 (estimated)
- Study completion20 Dec 2019 (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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HATİCE YAKUT, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132167
- Sponsor's protocol ID
- 12345
- Status last verified
- Oct 2019
- First submitted
- 23 Nov 2017
- Last updated
- 25 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Perturbation Training Results in Changes in Balance and Falling in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04132167
- Acronym / sponsor ID
- 12345
- Conditions
- Multiple Sclerosis
- Keywords
- Rehabilitation, Multiple sclerosis, Tailored interventions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 20 Oct 2019 (estimated)
- Study completion
- 20 Dec 2019 (estimated)
- First posted
- 18 Oct 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.
Physical exercise can prevent falls, certain types of exercise may be more effective. Perturbation-based balance training is a novel intervention involving repeated postural perturbations aiming to improve control of rapid balance reactions. The purpose of this study was to estimate the effect of perturbation- based balance training on falls and balance in daily life.Thirty patients with multiple sclerosis (PwMS) will assess with regard to dynamic balance, walking and falling. Patients randomly will allocate to a personalized (PRG) or traditional (TRG) rehabilitation group.
Detailed description
Thirty patients with multiple sclerosis (PwMS) will assess with regard to dynamic balance, walking and falling. Patients randomly will allocate to a personalized (PRG) or traditional (TRG) rehabilitation group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training group | Experimental | Procedure: perturbation trainingperturbation balance training |
| control group | Active comparator | Procedure: perturbation trainingtraditional physical therapy that including strengthening and stretching |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- An age older than 18 years
- Stable phase of the disease without relapses or worsening in the last three months
- Referring fear of falling or a history of falls (at least one fall in the last year).
- Individuals with a high level of balance.
Key exclusion criteria (5 listed)
- Psychiatric disorders
- Blurred vision
- Severe cognitive impairment
- Severely impaired upright postural control or limited participation in a rehabilitation program
- Cardiovascular and respiratory disorders.
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 |
|---|---|---|
| perturbation trainingexercises for body stability in different positions (bridge, sitting, quadrupedal, half- kneeling, kneeling, standing, monopodalic) performed with visual biofeedback; transfers training performed in front of a mirror; ambulation training with courses drawn on the ground in a straight line and with more complex tracks with visual controlin particular using the protocols seated balance/strength training, standing bal- ance/weight-bearing training, mobility training and closed-chain training; | Procedure or surgery | control group, training group |
Primary outcome
dynamic balance
Time frame: 6 week
the effects of perturbation dynamic balance training assessed with four square step test >15 seconds = increased risk of falls
walking
Time frame: 6 week
the effects of perturbation dynamic balance training assessed with 10 meter walking test
walking
Time frame: 6 week
the effects of perturbation dynamic balance training assessed with time up and go test(TUG).A score of 30 seconds or more suggests that the person may be prone to falls
falling
Time frame: 6 week
the effects of perturbation dynamic balance training assessed with Falling Efficacy Scale(FES). The FES is a 10-item test. On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all.
fear of falling
Time frame: 6 week
The short FES-I is a 7-item self-report questionnaire for measuring perceived self-efficacy to avoid a fall in various situations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
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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.
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 perturbation training in people with Multiple Sclerosis, run by Suleyman Demirel 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 4 inclusion and 5 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 25 Oct 2019. 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?
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?
dynamic balance (time frame: 6 week). The study lists 5 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 25 Oct 2019.