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

January 15, 2022 updated by: Huma Waqar, University of Lahore

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Faisalabad, Punjab, Pakistan, 38000
        • Recruiting
        • Physiotherapy department of Allied Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Routine physical therapy + Sensorimotor stimulation
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
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
Other: Routine physical therapy
Active and passive Range of motion exercise of upper and lower limb, Transfer from bed to chair, Sit to stand practice
Placebo Comparator: Routine physical therapy
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
Active and passive Range of motion exercise of upper and lower limb, Transfer from bed to chair, Sit to stand practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
16th week
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,
16th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Investigators

  • Principal Investigator: Huma Waqar, MS PTN*, University of Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2021

Primary Completion (Anticipated)

July 12, 2022

Study Completion (Anticipated)

July 22, 2022

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

January 31, 2022

Last Update Submitted That Met QC Criteria

January 15, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-UOL-FAHS/985/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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