Acute Effect of Fascial Mobilization on Gait in Patients With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fascial mobilization
Stretching Exercise
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Loading, Gait, Multiple Sclerosis, Manual Therapy
Eligibility Criteria
Inclusion Criteria:
- Want to participate
- Individuals with multiple sclerosis who can walk alone for 50 meters
- Healthy participants who diagnosed no disorders or orthopedic problems.
Exclusion Criteria:
- Do not want to participate
- Surgery history
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Fascial mobilization
Stretching exercise
Healthy Volunteers
Arm Description
First day intervention: Patients will take fascial mobilization techniques to management of plantar flexor spasticity
Second day intervention:Patients will take fascial mobilization techniques to management of plantar flexor spasticity
Healthy individuals will only be evaluated with no intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02628834
First Posted
November 11, 2015
Last Updated
December 9, 2015
Sponsor
Hacettepe University
1. Study Identification
Unique Protocol Identification Number
NCT02628834
Brief Title
Acute Effect of Fascial Mobilization on Gait in Patients With Multiple Sclerosis
Official Title
Investigating the Acute Effect of Fascial Mobilization on Dynamic Walking Parameters in Patients With Multiple Sclerosis: A Crossover Controlled Group Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Loading, Gait, Multiple Sclerosis, Manual Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fascial mobilization
Arm Type
Experimental
Arm Description
First day intervention: Patients will take fascial mobilization techniques to management of plantar flexor spasticity
Arm Title
Stretching exercise
Arm Type
Experimental
Arm Description
Second day intervention:Patients will take fascial mobilization techniques to management of plantar flexor spasticity
Arm Title
Healthy Volunteers
Arm Type
No Intervention
Arm Description
Healthy individuals will only be evaluated with no intervention
Intervention Type
Other
Intervention Name(s)
Fascial mobilization
Other Intervention Name(s)
manual therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stretching Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pedobarography for assessment of foot pressure while standing and walking.
Description
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.
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
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale for evaluation of severity of involuntary muscle contraction
Description
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
Time Frame
Initially evaluation at first minute, at 20th minutes, at 24 hours, at 24 hours and 20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Want to participate
Individuals with multiple sclerosis who can walk alone for 50 meters
Healthy participants who diagnosed no disorders or orthopedic problems.
Exclusion Criteria:
Do not want to participate
Surgery history
12. IPD Sharing Statement
Learn more about this trial
Acute Effect of Fascial Mobilization on Gait in Patients With Multiple Sclerosis
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