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

NCT05194644 | Unknown

• 1 other identifier: IRB-UOL-FAHS/985/2021
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Mild Traumatic Brain Injury

Keywords

Concussion

Outcome Measures

Primary Outcomes (2)

• 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

  16th week

• 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,

  16th week

Study Arms (2)

Routine physical therapy + Sensorimotor stimulation

EXPERIMENTAL

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; Other: Routine physical therapy

Routine physical therapy

PLACEBO COMPARATOR

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

Interventions

Routine physical therapy+ Sensorimotor stimulation OTHER

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

Routine physical therapy + Sensorimotor stimulation

Routine physical therapy OTHER

Active and passive Range of motion exercise of upper and lower limb, Transfer from bed to chair, Sit to stand practice

Routine physical therapy; Routine physical therapy + Sensorimotor stimulation

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient recruit from Outdoor patient department with mild traumatic brain injury having Glasgow coma scale score(13-15)
• Normal intracranial pressure
• Cardiopulmonary stability

You may not qualify if:

• Preexisting disabilities
• Suffering from severe medical disease
• Persistent vegetative state
• Patients with opium and drug addicted
• Patients with deafness and delusion disorders

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Physiotherapy department of Allied Hospital

Faisalabad, Punjab Province, 38000, Pakistan

RECRUITING

Related Publications (4)

• Nizamutdinov D, Shapiro LA. Overview of Traumatic Brain Injury: An Immunological Context. Brain Sci. 2017 Jan 23;7(1):11. doi: 10.3390/brainsci7010011.

  PMID: 28124982 BACKGROUND

• 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.

  PMID: 32035565 BACKGROUND

• 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.

  PMID: 28135424 BACKGROUND

• 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.

  PMID: 26679234 BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Huma Waqar, MS PTN*

  University of Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Haider Ullah Khan, MS PTN

CONTACT

03314127210; haiderullah@live.com

Fahad Tanveer, PhD

CONTACT

03314193741; fahadtanveer3.pt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI 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

Model Details: Parallel assignment

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 18, 2022
• Study Start: November 10, 2021
• Primary Completion: July 12, 2022
• Study Completion: July 22, 2022
• Last Updated: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)