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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
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Loading, Gait, Multiple Sclerosis, Manual Therapy

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    November 11, 2015
    Last Updated
    December 9, 2015
    Sponsor
    Hacettepe University
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    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

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

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