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Clinical Trials/NCT05194644
NCT05194644
Unknown
Not Applicable

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

University of Lahore1 site in 1 country54 target enrollmentNovember 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Traumatic Brain Injury
Sponsor
University of Lahore
Enrollment
54
Locations
1
Primary Endpoint
Balance
Last Updated
4 years ago

Overview

Brief Summary

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

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: 1. 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. 2. 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. 3. 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. 4. Auditory stimulation: Investigator will communicate directly to patients, familiar songs will be utilized, Time duration will be 4 min. 5. 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.

Registry
clinicaltrials.gov
Start Date
November 10, 2021
End Date
July 22, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Lahore
Responsible Party
Principal Investigator
Principal Investigator

Huma Waqar

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

University of Lahore

Eligibility Criteria

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

Outcomes

Primary Outcomes

Balance

Time Frame: 16th week

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

Cognitive Performance

Time Frame: 16th week

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,

Study Sites (1)

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