Effect of Sensory Integration Therapy on Gait Variability and Quality Of Life in Patients With Multiple Sclerosis

NCT07390201 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005138
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the impact of sensory integration therapy on individuals with multiple sclerosis (MS) by examining its effects on gait variability and overall quality of life.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (8)

• Step Length Variability

  Step length variability will be assessed using the Biodex Gait Trainer 2 TM system. Participants will walk on the treadmill at a self-selected comfortable pace for three minutes after a familiarization period of 3-5 minutes. Three successive trials will be conducted with 2-3 minutes rest between trials, and the average will be calculated. Lower coefficient of variance (CV) values indicate less gait variability and better gait stability.

  20 weeks

• Step cycle Variability

  Step cycle variability will be measured during continuous walking on the Biodex Gait Trainer 2 TM system. Following familiarization, participants will walk at a comfortable self-selected speed for three minutes. Three trials will be-performed with rest periods in between, and the average CV will be recorded. This measure reflects temporal gait consistency.

  20 weeks

• Walking Speed Variability

  Walking speed variability will be evaluated using the Biodex Gait Trainer 2 TM system. After familiarization, participants will walk continuously for three minutes at their comfortable self-selected pace. Three successive trials will be conducted with rest intervals between trials, and the average CV will be recorded to assess speed consistency during walking.

  20 weeks

• Single Support Time Variability (Time on Each Foot)

  Single support time (time spent on each foot during walking) variability will be assessed using the Biodex Gait Trainer 2 TM system. Following familiarization with the treadmill, participants will walk at comfortable speed for three minutes. Three trials will be performed with rest periods between trials, and the average CV will be calculated to evaluate single limb stance stability during gait.

  20 weeks

• Step Length Variability (Smartphone-Based Assessment)

  Step length will be assessed using a validated smartphone application with the device secured to the participant's third lumbar vertebra (L3-L5 level) using a waist band. Participants will walk along a 7-meter walkway. The smartphone's built-in sensors (accelerometer and gyroscope) will automatically record and calculate step length based on movement patterns.

  20 weeks

• Gait Velocity Variability (Smartphone-Based Assessment)

  Walking speed will be measured using a smartphone application validated for gait analysis. The smartphone will be positioned at the lumbar spine (L3-L5) using a secure waist band. Participants will complete walking trials over a 7 meter walkway (two trials). The application will automatically calculate walking speed from sensor data collected during each trial.

  20 weeks

• Step Time Variability (Smartphone-Based Assessment)

  Step time will be assessed using a smartphone-based gait analysis application with the device fixed to the participant's lower lumbar region (L3-L5 vertebral level) via waist band. Following the researcher's "start" command, participants will walk along a 7-meter pathway (two trials). The smartphone's sensors will automatically detect and measure the time taken to complete each stride cycle. asked to answer items referring to the activities past 4 weeks. Items within subscales will be totaled to provide a summed score for each subscale or dimension. The responses will be scored in standardized fashion and will be scaled from 0 to 100, where (0= represent the poorest health and 100= represent the best health) in each category. Each subscale can be used independently.

  20 weeks

• Timed 25 foot walk test

  The Timed 25-Foot Walk (T25FW) test will be used to assess lower-limb function by measuring the time required to walk 25 feet (7.5 m) as quickly and safely as possible. Patients will perform two trials, and the mean time will be recorded using a stopwatch. Walking speed will be calculated by dividing the distance by the average time, following standardized administration and safety procedures.

  20 weeks

Secondary Outcomes (1)

• Short-form 36 quality of life's (SF-36)

  20 weeks

Study Arms (2)

Conventional physical therapy program

ACTIVE COMPARATOR

The Patients in this group will be treated by the conventional physical therapy program, two times a week for eight successive weeks (16 sessions in total for 70 min and enough rest in between).

Other: Conventional physical therapy program

Conventional physical therapy program + Sensory integration therapy

EXPERIMENTAL

Patients in this group will be treated by the same conventional physical therapy program (30 min), in addition to sensory integration therapy program (SIT) (40 min). The most commonly duration and frequency of sessions will be 70 min and (16 treatment sessions for two times a week) for eight successive weeks.

Other: Conventional physical therapy program; Other: Sensory integration therapy

Interventions

Conventional physical therapy program OTHER

This group will undergo a conventional physical therapy program twice weekly for eight weeks (16 sessions), with each 70-minute session including rest as needed. Sessions consist of a 5-minute warm-up, an active phase with individualized moderate-intensity aerobic exercises (64-76% of maximum heart rate) such as marching and over-ground walking with progressive difficulty, along with lower-limb stretching and strengthening exercises. Each session ends with a 5-minute cool-down using gentle stretching or gradual reduction of activity to minimize stiffness and muscle soreness.

Conventional physical therapy program; Conventional physical therapy program + Sensory integration therapy

Sensory integration therapy OTHER

This group will receive a combined program of conventional physical therapy (30 minutes) and sensory integration therapy (40 minutes) twice weekly for eight weeks (16 sessions, 70 minutes each). Sessions include a warm-up, active phase, and cool-down. Sensory integration therapy targets proprioceptive, visual, and vestibular inputs through progressively challenging balance and gait exercises under varied sensory conditions (eyes open/closed, firm or compliant surfaces), incorporating external and internal perturbations and barefoot gait training, with difficulty individualized and rest provided to prevent fatigue.

Conventional physical therapy program + Sensory integration therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients diagnosed with MS of relapsing-remitting at least 1 year before this study.
• The Patient's age will range from 18-45.
• A stable MS disease without any episodes of relapse within three months before the study.
• The Expanded Disability Status Scale (EDSS) scale from medical documentation (2-4.5) involve that patients have (visual, cerebellum, pyramidal brainstem and sensory) problems.
• Ability to walk six minutes' walk test (6 min walk test)

You may not qualify if:

• Orthopedic disorders such as contracture deformities that could negatively affect gait.
• Other disorders affect gait and quality of life as (diabetes mellitus).
• Other diseases that affect Visual and vestibular problems system (such as vestibular neuritis).
• Marked spasticity grade (2,3,4) for bilateral lower extremities according to modified ashworth scale.
• Pregnancy.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Al Ainy Multiple Sclerosis Clinic

Giza, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Abeer Abo Bakr Elwishy, PhD

  Professor, Cairo University

  STUDY CHAIR

• Hossam Mohammed AlSaid, PhD

  Lecturer, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mai Mohamed Gamal Mahrous, M.Sc

CONTACT

+20 12 82368498; dr.maimahrous@gmail.com

Hossam Mohammed AlSaid, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): July 5, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

EG (1)