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

Multiple Sclerosis Clinical Trial

Official title:

Investigating the Acute Effect of Fascial Mobilization on Dynamic Walking Parameters in Patients With Multiple Sclerosis: A Crossover Controlled Group Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02628834
• Other study ID #: D/01070
• Status: Not yet recruiting
• Phase: N/A
• First received: November 11, 2015
• Last updated: December 9, 2015
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Fascial mobilization
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 Exercise
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Yes
Secondary	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	Initially evaluation at first minute, at 20th minutes, at 24 hours, at 24 hours and 20 minutes	Yes