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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Multiple Sclerosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07390201

P.T.REC/012/005138

Details and patient eligibility

About

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.

Full 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).

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Conventional physical therapy program

Active Comparator group

Description:

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).

Treatment:

Other: Conventional physical therapy program

Conventional physical therapy program + Sensory integration therapy

Experimental group

Description:

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.

Treatment:

Other: Sensory integration therapy

Other: Conventional physical therapy program