search
Back to results

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

Primary Purpose

Mild Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Routine physical therapy+ Sensorimotor stimulation
Routine physical therapy
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring Concussion

Eligibility Criteria

18 Years - 38 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Physiotherapy department of Allied HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Routine physical therapy + Sensorimotor stimulation

Routine physical therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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,

Secondary Outcome Measures

Full Information

First Posted
January 4, 2022
Last Updated
January 15, 2022
Sponsor
University of Lahore
search

1. Study Identification

Unique Protocol Identification Number
NCT05194644
Brief Title
Sensorimotor Stimulation, Routine Physical Therapy, Balance, Cognitive Performance Mild Traumatic Brain Injury Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
July 12, 2022 (Anticipated)
Study Completion Date
July 22, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury
Keywords
Concussion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine physical therapy + Sensorimotor stimulation
Arm Type
Experimental
Arm Description
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
Arm Title
Routine physical therapy
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Routine physical therapy+ Sensorimotor stimulation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Routine physical therapy
Intervention Description
Active and passive Range of motion exercise of upper and lower limb, Transfer from bed to chair, Sit to stand practice
Primary Outcome Measure Information:
Title
Balance
Description
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
Time Frame
16th week
Title
Cognitive Performance
Description
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,
Time Frame
16th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Haider Ullah Khan, MS PTN
Phone
03314127210
Email
haiderullah@live.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fahad Tanveer, PhD
Phone
03314193741
Email
fahadtanveer3.pt@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Waqar, MS PTN*
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiotherapy department of Allied Hospital
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Waqar Afzal, Phd*
Phone
03214668377
Email
waqar.afzal@uipt.uol.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28124982
Citation
Nizamutdinov D, Shapiro LA. Overview of Traumatic Brain Injury: An Immunological Context. Brain Sci. 2017 Jan 23;7(1):11. doi: 10.3390/brainsci7010011.
Results Reference
background
PubMed Identifier
32035565
Citation
Capizzi A, Woo J, Verduzco-Gutierrez M. Traumatic Brain Injury: An Overview of Epidemiology, Pathophysiology, and Medical Management. Med Clin North Am. 2020 Mar;104(2):213-238. doi: 10.1016/j.mcna.2019.11.001.
Results Reference
background
PubMed Identifier
28135424
Citation
Swanson TM, Isaacson BM, Cyborski CM, French LM, Tsao JW, Pasquina PF. Traumatic Brain Injury Incidence, Clinical Overview, and Policies in the US Military Health System Since 2000. Public Health Rep. 2017 Mar/Apr;132(2):251-259. doi: 10.1177/0033354916687748. Epub 2017 Jan 30.
Results Reference
background
PubMed Identifier
26679234
Citation
Finch E, Copley A, Cornwell P, Kelly C. Systematic Review of Behavioral Interventions Targeting Social Communication Difficulties After Traumatic Brain Injury. Arch Phys Med Rehabil. 2016 Aug;97(8):1352-65. doi: 10.1016/j.apmr.2015.11.005. Epub 2015 Dec 8.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs