NCT02628834

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Dec 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

November 11, 2015

Last Update Submit

December 9, 2015

Conditions

Keywords

LoadingGaitMultiple SclerosisManual Therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Modified Ashworth Scale for evaluation of severity of involuntary muscle contraction

    Initially evaluation at first minute, at 20th minutes, at 24 hours, at 24 hours and 20 minutes

Study Arms (3)

Fascial mobilization

EXPERIMENTAL

First day intervention: Patients will take fascial mobilization techniques to management of plantar flexor spasticity

Other: Fascial mobilization

Stretching exercise

EXPERIMENTAL

Second day intervention:Patients will take fascial mobilization techniques to management of plantar flexor spasticity

Other: Stretching Exercise

Healthy Volunteers

NO INTERVENTION

Healthy individuals will only be evaluated with no intervention

Interventions

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.

Also known as: manual therapy
Fascial mobilization

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.

Stretching exercise

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Want to participate
  • Individuals with multiple sclerosis who can walk alone for 50 meters
  • Healthy participants who diagnosed no disorders or orthopedic problems.

You may not qualify if:

  • Do not want to participate
  • Surgery history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Musculoskeletal ManipulationsMuscle Stretching Exercises

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationExercise TherapyAftercareContinuity of Patient CarePatient CareExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, PT

Study Record Dates

First Submitted

November 11, 2015

First Posted

December 11, 2015

Study Start

December 1, 2015

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

December 11, 2015

Record last verified: 2015-12