Multiple SclerosisNCT02628834
Acute Effect of Fascial Mobilization on Gait in Patients With Multiple Sclerosis
A study testing Fascial mobilization and Stretching Exercise in people with Multiple Sclerosis, run by Hacettepe University.
Trial summary
Ten patients who were referred to receive physiotherapy and 10 healthy volunteers will be participants of the study.Following the initial evaluation, participants with multiple sclerosis will take the fascial mobilization for their posterior crural muscle group and hamstring distal tendons which connects the crural… Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Fascial mobilization and Stretching Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2016
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Want to participate
- Individuals with multiple sclerosis who can walk alone for 50 meters
- Healthy participants who diagnosed no disorders or orthopedic problems.
Who cannot join
- Do not want to participate
- Surgery history
About this study
Official title: Investigating the Acute Effect of Fascial Mobilization on Dynamic Walking Parameters in Patients With Multiple Sclerosis: A Crossover Controlled Group Study
Ten patients who were referred to receive physiotherapy and 10 healthy volunteers will be participants of the study.Following the initial evaluation, participants with multiple sclerosis will take the fascial mobilization for their posterior crural muscle group and hamstring distal tendons which connects the crural bones at first day. After the day following the first visit participants will asked to come again and stretching exercises will apply to plantar muscle groups after the evaluation. Every participants will evaluate with the following assessment tools: Modified Ashworth scale will use to evaluation of severity of plantar flexor spasticity. Static and dynamic loading parameters will assess with dynamic pedobarography.
Read the detailed description
Ten patients who were referred to receive physiotherapy at the neurology department of Physiotherapy and Rehabilitation of the Faculty of Health Sciences of Hacettepe University, Ankara with multiple sclerosis and ten voluntary healthy age matched participants will be the subjects of this study.
Following the initial evaluation, participants with multiple sclerosis will take the fascial mobilization (FM) for their posterior crural muscle group and hamstring distal tendons which connects the crural bones at first day. After the day following the first visit participants will ask to come again and stretching exercises will apply to plantar muscle groups after the evaluation. In the investigators' study fascial mobilization will use to release plantar flexor muscles and fascia because it is believed to not aggravate the spasticity and is widely used in clinical practice. Fascial mobilization will applied regarding the following strategies.
The patient lied on prone position with knee extension and therapist put the patient's plantar surface to her femoral region. Achilles, tibialis posterior, perenous longus and brevis distal tendons, gastrocnemius proximal tendons, hamstring's distal tendons will mobilize at first stage. The second stage of fascia mobilization includes the deep fascial mobilization of posterior crural muscle trunks. After that, the skin also gently mobilize. During fascial mobilization, once the spastic muscles relaxation were appeared, the ankle is been moved to dorsiflexion gradually. FM will carry out for 15 minutes for each foot.
Same patients will receive also stretching exercises consisted of 30 s stretching and 10 s resting periods and will carry out for 15 minutes for each foot at second day after the first evaluation.Fourteen healthy volunteers will receive no interventions.
Assessments will utilize at initially and after FM were applied at first visit. The day after patients will asked to come again and initially evaluations will repeat before stretching exercises. After stretching exercises patients will evaluate again with same tools.
Assessment tools described as following: Modified Ashworth scale will use to evaluate of severity of plantar flexor spasticity. Static and dynamic loading parameters will be evaluate with pedobarography.Maximum loading pressure -N/cm2, maximum loading time- ms for; 1st. and 5th metatarsal head, medial and lateral heel and midfoot will be recorded both while the patients standing and walking.
- Conditions
- Multiple Sclerosis
- Being tested
- Fascial mobilization, Stretching Exercise
- Keywords
- Loading, Gait, Multiple Sclerosis, Manual Therapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial mobilizationOther
Also called manual therapy
The patient will lie on prone position with knee extension and therapist put the patient's plantar surface to her femoral region. Achilles, tibialis posterior, perenous longus and brevis distal tendons, gastrocnemius proximal tendons, hamstring's distal tendons will be mobilized at first stage. The second stage of fascia mobilization included the deep fascial mobilization of posterior crural muscle trunks. After that, the skin also will be gently mobilized. During fascial mobilization, once the spastic muscles relaxation will appeared, the ankle will move to dorsiflexion gradually. FM will carry out for 15 minutes for each foot.
Stretching ExerciseOther
Patients will receive also stretching exercises consisted of 30 s stretching and 10 s resting periods and will carry out for 15 minutes for each foot at second day after the first evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Fascial mobilization | Experimental | First day intervention: Patients will take fascial mobilization techniques to management of plantar flexor spasticity Receives: Other: Fascial mobilization |
| Stretching exercise | Experimental | Second day intervention:Patients will take fascial mobilization techniques to management of plantar flexor spasticity Receives: Other: Stretching Exercise |
| Healthy Volunteers | No intervention | Healthy individuals will only be evaluated with no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pedobarography for assessment of foot pressure while standing and walking.
Participant stands and walks on system name is pedobarography which records foot pressure, for 7 minutes. Foot pressure means, gravitational force reflecting from ground at every foot step phase. Newton/cm2 is the unit of measure.
Measured: Initially evaluation at first minute, Change from initial evaluation to 20th minutes, Change from initial evaluation to 24 hours, Change from initial evaluation to 24 hours and 20 minutes
Secondary outcomes (1)
Modified Ashworth Scale for evaluation of severity of involuntary muscle contraction
Modified Ashworth Scale is an assessment method gives severity of involuntary contraction of muscle. Evaluator gives point from 0 to 4 according to muscle reflection to stretching
Measured: Initially evaluation at first minute, at 20th minutes, at 24 hours, at 24 hours and 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (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.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hhotaman, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628834
- Sponsor's protocol ID
- D/01070
- Status last verified
- Dec 2015
- First submitted
- 11 Nov 2015
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Acute Effect of Fascial Mobilization on Dynamic Walking Parameters in Patients With Multiple Sclerosis: A Crossover Controlled Group Study
- ClinicalTrials.gov ID
- NCT02628834
- Acronym / sponsor ID
- D/01070
- Conditions
- Multiple Sclerosis
- Keywords
- Loading, Gait, Multiple Sclerosis, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Dec 2015 (estimated)
- 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.
Ten patients who were referred to receive physiotherapy and 10 healthy volunteers will be participants of the study.Following the initial evaluation, participants with multiple sclerosis will take the fascial mobilization for their posterior crural muscle group and hamstring distal tendons which connects the crural bones at first day. After the day following the first visit participants will asked to come again and stretching exercises will apply to plantar muscle groups after the evaluation. Every participants will evaluate with the following assessment tools: Modified Ashworth scale will use to evaluation of severity of plantar flexor spasticity. Static and dynamic loading parameters will assess with dynamic pedobarography.
Detailed description
Ten patients who were referred to receive physiotherapy at the neurology department of Physiotherapy and Rehabilitation of the Faculty of Health Sciences of Hacettepe University, Ankara with multiple sclerosis and ten voluntary healthy age matched participants will be the subjects of this study.
Following the initial evaluation, participants with multiple sclerosis will take the fascial mobilization (FM) for their posterior crural muscle group and hamstring distal tendons which connects the crural bones at first day. After the day following the first visit participants will ask to come again and stretching exercises will apply to plantar muscle groups after the evaluation. In the investigators' study fascial mobilization will use to release plantar flexor muscles and fascia because it is believed to not aggravate the spasticity and is widely used in clinical practice. Fascial mobilization will applied regarding the following strategies.
The patient lied on prone position with knee extension and therapist put the patient's plantar surface to her femoral region. Achilles, tibialis posterior, perenous longus and brevis distal tendons, gastrocnemius proximal tendons, hamstring's distal tendons will mobilize at first stage. The second stage of fascia mobilization includes the deep fascial mobilization of posterior crural muscle trunks. After that, the skin also gently mobilize. During fascial mobilization, once the spastic muscles relaxation were appeared, the ankle is been moved to dorsiflexion gradually. FM will carry out for 15 minutes for each foot.
Same patients will receive also stretching exercises consisted of 30 s stretching and 10 s resting periods and will carry out for 15 minutes for each foot at second day after the first evaluation.Fourteen healthy volunteers will receive no interventions.
Assessments will utilize at initially and after FM were applied at first visit. The day after patients will asked to come again and initially evaluations will repeat before stretching exercises. After stretching exercises patients will evaluate again with same tools.
Assessment tools described as following: Modified Ashworth scale will use to evaluate of severity of plantar flexor spasticity. Static and dynamic loading parameters will be evaluate with pedobarography.Maximum loading pressure -N/cm2, maximum loading time- ms for; 1st. and 5th metatarsal head, medial and lateral heel and midfoot will be recorded both while the patients standing and walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fascial mobilization | Experimental | Other: Fascial mobilizationFirst day intervention: Patients will take fascial mobilization techniques to management of plantar flexor spasticity |
| Stretching exercise | Experimental | Other: Stretching ExerciseSecond day intervention:Patients will take fascial mobilization techniques to management of plantar flexor spasticity |
| Healthy Volunteers | No intervention | –Healthy individuals will only be evaluated with no intervention |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Want to participate
- Individuals with multiple sclerosis who can walk alone for 50 meters
- Healthy participants who diagnosed no disorders or orthopedic problems.
Key exclusion criteria (2 listed)
- Do not want to participate
- Surgery history
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 |
|---|---|---|
| Fascial mobilizationAlso: manual therapyThe patient will lie on prone position with knee extension and therapist put the patient's plantar surface to her femoral region. Achilles, tibialis posterior, perenous longus and brevis distal tendons, gastrocnemius proximal tendons, hamstring's distal tendons will be mobilized at first stage. The second stage of fascia mobilization included the deep fascial mobilization of posterior crural muscle trunks. After that, the skin also will be gently mobilized. During fascial mobilization, once the spastic muscles relaxation will appeared, the ankle will move to dorsiflexion gradually. FM will carry out for 15 minutes for each foot. | Other | Fascial mobilization |
| Stretching ExercisePatients will receive also stretching exercises consisted of 30 s stretching and 10 s resting periods and will carry out for 15 minutes for each foot at second day after the first evaluation. | Other | Stretching exercise |
Primary outcome
Pedobarography for assessment of foot pressure while standing and walking.
Time frame: Initially evaluation at first minute, Change from initial evaluation to 20th minutes, Change from initial evaluation to 24 hours, Change from initial evaluation to 24 hours and 20 minutes
Participant stands and walks on system name is pedobarography which records foot pressure, for 7 minutes. Foot pressure means, gravitational force reflecting from ground at every foot step phase. Newton/cm2 is the unit of measure.
1 secondary outcome
Modified Ashworth Scale for evaluation of severity of involuntary muscle contraction
Time frame: Initially evaluation at first minute, at 20th minutes, at 24 hours, at 24 hours and 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Fascial mobilization and Stretching Exercise in people with Multiple Sclerosis, run by Hacettepe University.
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 3 inclusion and 2 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 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Pedobarography for assessment of foot pressure while standing and walking. (time frame: Initially evaluation at first minute, Change from initial evaluation to 20th minutes, Change from initial evaluation to 24 hours, Change from initial evaluation to 24 hours and 20 minutes). 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 11 Dec 2015.