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Multiple SclerosisNCT07390201

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

A study testing Conventional physical therapy program and Sensory integration therapy in people with Multiple Sclerosis, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Conventional physical therapy program and Sensory integration therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteEgypt
Study dates
5 Feb 2026to 20 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Kasr Al Ainy Multiple Sclerosis Clinic

    Giza

Other trials in Egypt

About this study

Official title: Effect of Sensory Integration Therapy on Gait Variability and Quality Of Life in Patients With Multiple Sclerosis: A Randomized Controlled Trial

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.

Read the detailed description

Rehabilitation interventions within the neurorehabilitation domain (e.g. physiotherapy) have been shown to be beneficial in improving gait disorders in MS, functioning and QoL despite progression of MS. Several systematic reviews report on evidence of rehabilitation in general as well as on specific modalities, e.g. exercise. Therefore, development of affordable and convenient rehabilitation strategies must be emphasized.

Studies report that sensory dysfunctions in patients with multiple sclerosis primarily play a key role in disrupting motor control and mobility including gait abnormalities, reduced balance, altered alignment, range of motion, and coordination. Only a handful of studies have analyzed the effects of external sensory stimulations (auditory, visual) on motor performance in patients with multiple sclerosis. Sensory inputs are a necessary component for motor control and movement performance. Interaction among somatosensory, visual, and vestibular systems is essential for normal motor responses, balance control and mobility. Up to knowledge, there are lack of studies that investigate the effect of sensory integration therapy program on gait variability and quality of life in patients with Multiple Sclerosis. A study states that sensory integration therapy improves a children's capacity to analyze and integrate sensory data by incorporating various visual processing, kinesthetic awareness, tactile awareness, visuomotor coordination development, vestibular and proprioceptive activities. The goal of sensory integration therapy (SIT) is to improve the individual ability to integrate sensory information by strengthening each of the sensory systems (vestibular, proprioception and visual systems).

Being tested
Conventional physical therapy program, Sensory integration therapy
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional physical therapy programOther

    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.

  • Sensory integration therapyOther

    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.

Study groups in NCT07390201
Study groupRoleWhat they receive
Conventional physical therapy programActive comparatorThe 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).
Receives: Other: Conventional physical therapy program
Conventional physical therapy program + Sensory integration therapyExperimentalPatients 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.
Receives: Other: Conventional physical therapy program; Other: Sensory integration therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 CV values indicate less gait variability and better gait stability.

    Measured: 20 weeks

  2. 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.

    Measured: 20 weeks

  3. 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.

    Measured: 20 weeks

  4. 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.

    Measured: 20 weeks

  5. Coefficient of Variability of Gait (on each foot)

    Coefficient of Variability of Gait (CoV) (This is calculated as the amount of variation occurring between footfalls, expressed as a percentage). 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 coefficient of variability on each foot during gait. [Time Frame: 20 weeks

    Measured: 20 weeks

  6. Ambulation Index

    Ambulation Index (is a composite score relative to 100 based on foot-to-foot time distribution ratio and average step cycle. The goal is 100). Ambulation Index 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 coefficient of variability on each foot during gait.

    Measured: 20 weeks

  7. Step Length Variability (Smartphone-Based Assessment)

    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.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.

    Measured: 20 weeks

  8. 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. The average of two bouts will be calculated.

    Measured: 20 weeks

  9. 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. The average will be calculated

    Measured: 20 weeks

  10. Step length symmetry (%) (Smartphone-Based Assessment)

    Step length symmetry 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 data collected during each trial. The average of two bouts will be calculated

    Measured: 20 weeks

  11. Step time symmetry (%) (Smartphone-Based Assessment)

    Step time symmetry 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 data collected during each trial. The average of two bouts will be calculated.

    Measured: 20 weeks

  12. Total Time (sec) (Smartphone-Based Assessment)

    Total 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 data collected during each trial. The average of two bouts will be calculated.

    Measured: 20 weeks

  13. 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.

    Measured: 20 weeks

Secondary outcomes (1)
  1. Short-form 36 quality of life's (SF-36)

    The patients will sit in a comfortable relaxed position. The patients will be asked to answer items referring to the activities past 4 weeks. Items within (eight) 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.

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start5 Feb 2026
  3. Primary completion20 Jul 2026
  4. Study completion20 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07390201
Sponsor's protocol ID
P.T.REC/012/005138
Status last verified
Aug 2026
First submitted
29 Jan 2026
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Conventional physical therapy program and Sensory integration therapy in people with Multiple Sclerosis, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Step Length Variability (time frame: 20 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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