Clinical trial NCT05194644: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: Concussion
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: Balance
timeFrame: 16th week
measure: Cognitive Performance
timeFrame: 16th week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Physiotherapy department of Allied Hospital
state: Punjab
Study officials:
affiliation: University of Lahore
name: Huma Waqar, MS PTN*
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.