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

Not Applicable

• Conditions: Mild Traumatic Brain Injury

• Registration Number: NCT05194644
• Lead Sponsor: University of Lahore

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.

Study Timeline

• Study Start: 2021-11-10
• Status Verified: 2022-01
• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-04
• Last Update Submitted: 2022-01-15
• Study First Posted: 2022-01-18
• Last Update Posted: 2022-01-31
• Primary Completion: 2022-07-12
• Study Completion: 2022-07-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Balance	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	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,

Trial Locations

Locations (1)

Physiotherapy department of Allied Hospital; 🇵🇰 Faisalabad, Punjab, Pakistan