Acute Effect of Fascial Mobilization on Gait in Patients With Multiple Sclerosis

December 9, 2015 updated by: hhotaman, Hacettepe University

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.

Study Overview

Status

Unknown

Conditions

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fascial mobilization
First day intervention: Patients will take fascial mobilization techniques to management of plantar flexor spasticity
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.
Other Names:
  • manual therapy
Experimental: Stretching exercise
Second day intervention:Patients will take fascial mobilization techniques to management of plantar flexor spasticity
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.
No Intervention: Healthy Volunteers
Healthy individuals will only be evaluated with no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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
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
Initially evaluation at first minute, at 20th minutes, at 24 hours, at 24 hours and 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Estimate)

December 11, 2015

Last Update Submitted That Met QC Criteria

December 9, 2015

Last Verified

December 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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