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

Mild Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05194644
• Other study ID #: IRB-UOL-FAHS/985/2021
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2021
• Est. completion date: July 22, 2022

Study information

• Verified date: January 2022
• Source: University of Lahore
• Contact: Muhammad Haider Ullah Khan, MS PTN
• Phone: 03314127210
• Email: haiderullah[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: July 22, 2022
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Pakistan	Physiotherapy department of Allied Hospital	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. Review. — View 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. Review. — View Citation

Nizamutdinov D, Shapiro LA. Overview of Traumatic Brain Injury: An Immunological Context. Brain Sci. 2017 Jan 23;7(1). pii: E11. doi: 10.3390/brainsci7010011. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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