- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06721663
Multisensory Environment Stimulation Therapy on Postural Control in Cerebral Palsy
Effect of Multisensory Environment Stimulation Therapy on Postural Control in Spastic Hemiplegic Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Fortypatients with spastic hemiplegic cerebral palsy will participate in this study.
The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to Multisensory environment stimulation therapy, three times per week for three months. The evaluation methods are BIODEX, The Pediatric Balance Scale, and multidirection reach test
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Select State
-
Al Jīzah, Select State, Egypt
- Lama S Mahmoud
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- - Forty children with cerebral palsy,
- Age will range as (9:12) years old
- spastic hemiplegic cerebral palsy
- Normal body mass index standardmore than 50th and less than 85th for age and sex compared to standard Egyptian growth charts adopted by the Faculty of Medicine, Cairo University and National Research Centre.
- Gross motor function classification system: level I&II
Exclusion Criteria:
• difficulty to communicate or to understand program instructions
- any other neurological deficits or orthopaedic abnormalities,
- secondary musculoskeletal complication
- vestibular problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: study group
|
A Multi Sensory Environment is a dedicated space or room where sensory stimulation can be controlled (intensified or reduced), presented in isolation or combination, packaged for active or passive interaction
therapeutic balance training and functional therapeutic exercises
|
|
Experimental: control group
|
therapeutic balance training and functional therapeutic exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
biodex balance system
Time Frame: three months
|
EVALUATION OF POSTURAL BALANCE USINGTHE BIODEX BALANCE SYSTEM
|
three months
|
|
The Pediatric Balance Scale
Time Frame: three months
|
used to assess functional balance skills in school-aged children.
The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
|
three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
multidirection reach test
Time Frame: three months
|
The Multi-Directional Reach Test (MDRT) measures balance and the limits of stability in the anterior-posterior and medial-lateral directions by testing how far an individual can voluntarily reach forward, to the right, to the left, and lean backward, while standing with their feet flat on the ground
|
three months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012005472
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Ankara City Hospital BilkentRecruitingCerebral Palsy (CP) | Cerebral Palsy, Spastic, Diplegic | Diplegic Cerebral Palsy With Spasticity | Transcranial Magnetic StimilationTurkey (Türkiye)
-
Lahore University of Biological and Applied SciencesRecruiting
-
Suleyman Demirel UniversityCompletedCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Diplegia Cerebral PalsyTurkey (Türkiye)
-
Holland Bloorview Kids Rehabilitation HospitalCanadian Institutes of Health Research (CIHR)RecruitingCerebral Palsy (CP) | Hemiplegic Cerebral PalsyCanada
-
Cairo UniversityCompletedCerebral Palsy (CP) | Unilateral Cerebral PalsyEgypt
-
University of California, San FranciscoNot yet recruitingCerebral Palsy | Cerebral Palsy (CP) | Infant | Cerebral Palsy InfantileUnited States
-
Lahore University of Biological and Applied SciencesNot yet recruitingSpastic Diplegia Cerebral PalsyPakistan
-
IRCCS Fondazione Stella MarisNot yet recruitingCerebral Palsy (CP) | EEG | Unilateral Cerebral Palsy | Action ObservationItaly
-
IRCCS Fondazione Stella MarisUniversity of Siena, ItalyRecruitingCerebral Palsy (CP) | Motor Imagery | CP (Cerebral Palsy) | Action ObservationItaly
-
University of LahoreCompletedCerebral Palsy (CP) | Spastic Diplegia Cerebral Palsy | Balance | Gross Motor FunctionsPakistan
Clinical Trials on Multisensory environment stimulation therapy
-
The Hong Kong Polytechnic UniversityCompletedMuscle Hypotonia | Behavior DisturbanceHong Kong
-
Bilecik Seyh Edebali UniversitesiNot yet recruitingPostoperative Pain | Fear | Child, Only | Multisensory Stimulation
-
Asir John SamuelMaharishi Markendeswar University (Deemed to be University); Department of...CompletedNeonatal Disease | Neonatal DisorderIndia
-
Hacettepe UniversityEnrolling by invitationRehabilitation | Sensory Processing Disorder | Occupational Therapy | Caregiver Burnout | Behavioral and Psychiatric Symptoms of Dementia | Cognitive | Alzheimer s DiseaseTurkey (Türkiye)
-
Jianan Psychiatric Center, Ministry of Health and...National Cheng Kung University; Taiwan Nurses AssociationCompletedPsychotic Disorders | Anxiety | Complementary Therapies | Clinical TrialTaiwan
-
Alexandria UniversityCompletedPreterm NeonatesEgypt
-
Unity Health TorontoTerminatedTraumatic Brain Injury With Prolonged Loss of ConsciousnessCanada
-
Mahidol UniversityRecruitingAutism Spectrum Disorder | AutismThailand
-
Institut GuttmannThe University of QueenslandUnknownBrain Injuries, Traumatic | Alteration of Cognitive Function | Confusional State | Sensory Motor System DisorderSpain
-
Tung Wah CollegeCompleted