Sensorimotor Stimulation, Routine Physical Therapy, Balance, Cognitive Performance Mild Traumatic Brain Injury Patients

Study Overview
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Brief Summary
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Study design: Randomized controlled trial Settings: Physiotherapy department of Allied hospital, Faisalabad Sample size: 27 in each group Control group receive: Routine physical therapy Experimental group receive: Routine physical therapy+ Sensorimotor stimulation

Detailed Description
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Control group: Routine physical therapy Time duration: 20 min, Rest period: 5 min and treatment will be given 5 days a week and continued for 16 weeks. Experimental group: Routine physical therapy + Sensorimotor stimulation Sensorimotor stimulation: Sensory stimulation: Gustatory stimulation: Irrigation of oral cavity, brushing of teeth and tongue, gum massage, 2ml lemon juice on lateral side of tongue, Time duration will be 4 min. Tactile stimulation: For temperature sensation warm and cold water will applied on different body parts, For touch sensation wet towels and soap will be applied, For pressure sensation body parts will be massaged by lotion, Time duration will be 4 min. Olfactory stimulation: Aromatic stimuli with fragrances to which patient had been familiar e.g. coffee, tea, orange peel and perfume etc. Time duration will be 3 min. Auditory stimulation: Investigator will communicate directly to patients, familiar songs will be utilized, Time duration will be 4 min. Visual stimulation: Colored light, familiar faces, photographs of family members, moving light will be used, Time duration will be 4 min. Motor stimulation: Warm up session for 5-10 min, Strengthening exercises for upper and lower limb, for trunk flexors and abdominal curls in supine lying, 10rep 2 sets for 3 times a week, Different balance exercise for 6 min 5 times a week.

Official Title
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Effects of Sensorimotor Stimulation Program With and Without Routine Physical Therapy on Balance and Cognitive Performance in Patients With Mild Traumatic Brain Injury: A Randomized Controlled Trial

Conditions
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Mild Traumatic Brain Injury

Intervention / Treatment
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* Other: Routine physical therapy+ Sensorimotor stimulation
* Other: Routine physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient recruit from Outdoor patient department with mild traumatic brain injury having Glasgow coma scale score(13-15) Normal intracranial pressure Cardiopulmonary stability Exclusion Criteria: Preexisting disabilities Suffering from severe medical disease Persistent vegetative state Patients with opium and drug addicted Patients with deafness and delusion disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Routine physical therapy + Sensorimotor stimulation<br>Active and passive Range of motion exercise on upper and lower limb, Transfers from bed to chair, Sit to stand exercise Time duration will be 20 min, Rest period 5 min In Sensory Stimulation Gustatory, Tactile, Olfactory, Visual, Auditory Stimulation will be applied alternatively Time duration will be 4 min In motor stimulation first warm up session for 5-10 min, strengthening exercise, PNF techniques for upper and lower limb, abdominal curls and then different Balance exercises for 6 min 5 times a week | Other: Routine physical therapy+ Sensorimotor stimulation<br>* Gustatory, Tactile, Olfactory, Visual and Auditory Stimulation will be applied in sensory stimulation and in motor stimulation strengthening, Proprioceptive neuromuscular facilitation techniques, Balance exercises will be performed<br>Other: Routine physical therapy<br>* Active and passive Range of motion exercise of upper and lower limb, Transfer from bed to chair, Sit to stand practice<br>|
| Placebo Comparator: Routine physical therapy<br>Active and passive Range of motion exercise on upper and lower limb, Transfers from bed to chair, Sit to stand exercise Time duration will be 20 min, Rest period 5 min | Other: Routine physical therapy<br>* Active and passive Range of motion exercise of upper and lower limb, Transfer from bed to chair, Sit to stand practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance | Balance will be measured by Berg balance scale in which (0-20)indicates high fall risk, (21-40) indicates medium fall risk and (41-56) represents low fall risk | 16th week | 
| Cognitive Performance | Cognitive performance will be measured by Rancho Los Amigos scale that consist of 8 levels. level I indicates no response and needs total assistance whereas level VIII represents purposeful appropriate response and needs stand by assistance, | 16th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Concussion