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

Sponsor
University of Lahore (Other)
Overall Status
Recruiting
CT.gov ID
NCT05194644
Collaborator
(none)
54
1
2
8.3
6.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Routine physical therapy+ Sensorimotor stimulation
  • Other: Routine physical therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel assignmentParallel assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 10, 2021
Anticipated Primary Completion Date :
Jul 12, 2022
Anticipated Study Completion Date :
Jul 22, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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,

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 38 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Physiotherapy department of Allied Hospital Faisalabad Punjab Pakistan 38000

Sponsors and Collaborators

  • University of Lahore

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
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
ClinicalTrials.gov Identifier:
NCT05194644
Other Study ID Numbers:
  • IRB-UOL-FAHS/985/2021
First Posted:
Jan 18, 2022
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by 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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2022