Multiple Sclerosis
Conditions
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.
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).
Interventions
OTHERConventional physical therapy program
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.
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Step Length Variability | 20 weeks | 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. |
| Step cycle Variability | 20 weeks | 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. |
| Walking Speed Variability | 20 weeks | 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. |
| Single Support Time Variability (Time on Each Foot) | 20 weeks | 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. |
| Coefficient of Variability of Gait (on each foot) | 20 weeks | 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 |
| Ambulation Index | 20 weeks | 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. |
| Step Length Variability (Smartphone-Based Assessment) | 20 weeks | 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. |
| Gait Velocity Variability (Smartphone-Based Assessment) | 20 weeks | 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. |
| Step Time Variability (Smartphone-Based Assessment) | 20 weeks | 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 |
| Step length symmetry (%) (Smartphone-Based Assessment) | 20 weeks | 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 |
| Step time symmetry (%) (Smartphone-Based Assessment) | 20 weeks | 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. |
| Total Time (sec) (Smartphone-Based Assessment) | 20 weeks | 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. |
| Timed 25 foot walk test | 20 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-form 36 quality of life's (SF-36) | 20 weeks | 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. |
Countries
Egypt
Contacts
STUDY_CHAIRAbeer Abo Bakr Elwishy, PhD
Professor, Cairo University
STUDY_DIRECTORHossam Mohammed AlSaid, PhD
Lecturer, Cairo University
Outcome results
None listed