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

NCT ID: NCT05194644

Last Updated: 2022-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-10

Study Completion Date

2022-07-22

Brief Summary

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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

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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.

Conditions

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Mild Traumatic Brain Injury

Keywords

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Concussion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Routine physical therapy+ Sensorimotor stimulation

Intervention Type 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

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Routine physical therapy

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lahore

OTHER

Sponsor Role lead

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huma Waqar, MS PTN*

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Locations

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Physiotherapy department of Allied Hospital

Faisalabad, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Muhammad Haider Ullah Khan, MS PTN

Role: CONTACT

Phone: 03314127210

Email: [email protected]

Fahad Tanveer, PhD

Role: CONTACT

Phone: 03314193741

Email: [email protected]

Facility Contacts

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Dr Waqar Afzal, Phd*

Role: primary

References

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

Reference Type BACKGROUND
PMID: 28124982 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32035565 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28135424 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26679234 (View on PubMed)

Other Identifiers

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IRB-UOL-FAHS/985/2021

Identifier Type: -

Identifier Source: org_study_id