Mild Traumatic Brain InjuryNCT05194644
Sensorimotor Stimulation, Routine Physical Therapy, Balance, Cognitive Performance Mild Traumatic Brain Injury Patients
A study testing Routine physical therapy+ Sensorimotor stimulation and Routine physical therapy in people with Mild Traumatic Brain Injury, run by University of Lahore at 1 site in Pakistan.
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 Read more about this study
- Who is it for?
- Ages 18 to 38 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Routine physical therapy+ Sensorimotor stimulation and Routine physical therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Nov 2021to 22 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient recruit from Outdoor patient department with mild traumatic brain injury having Glasgow coma scale score(13-15)
- Normal intracranial pressure
- Cardiopulmonary stability
Who cannot join
- Preexisting disabilities
- Suffering from severe medical disease
- Persistent vegetative state
- Patients with opium and drug addicted
- Patients with deafness and delusion disorders
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Physiotherapy department of Allied Hospital
Faisalabad, Punjab Province, 38000
Dr Waqar Afzal, Phd*, 03214668377, waqar.afzal@uipt.uol.edu.pk
About this study
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 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
Read the 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.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Routine physical therapy+ Sensorimotor stimulation, Routine physical therapy
- Keywords
- Concussion
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine physical therapy+ Sensorimotor stimulationOther
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 therapyOther
Active and passive Range of motion exercise of upper and lower limb, Transfer from bed to chair, Sit to stand practice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Routine physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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,
Measured: 16th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start10 Nov 2021
- Primary completion12 Jul 2022 (estimated)
- Study completion22 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huma Waqar, University of Lahore
- Investigators
- Huma Waqar, MS PTN*, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194644
- Sponsor's protocol ID
- IRB-UOL-FAHS/985/2021
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nizamutdinov D, Shapiro LA. Overview of Traumatic Brain Injury: An Immunological Context. Brain Sci. 2017 Jan 23;7(1):11. doi: 10.3390/brainsci7010011.
PubMed 28124982Capizzi 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.
PubMed 32035565Swanson 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.
PubMed 28135424Finch 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.
PubMed 26679234
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05194644
- Acronym / sponsor ID
- IRB-UOL-FAHS/985/2021
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Concussion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 12 Jul 2022 (estimated)
- Study completion
- 22 Jul 2022 (estimated)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Routine physical therapy + Sensorimotor stimulation | Experimental | Other: Routine physical therapy+ Sensorimotor stimulation, Other: Routine physical therapyActive 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 |
| Routine physical therapy | Placebo comparator | Other: Routine physical therapyActive 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 |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient recruit from Outdoor patient department with mild traumatic brain injury having Glasgow coma scale score(13-15)
- Normal intracranial pressure
- Cardiopulmonary stability
Key exclusion criteria (5 listed)
- Preexisting disabilities
- Suffering from severe medical disease
- Persistent vegetative state
- Patients with opium and drug addicted
- Patients with deafness and delusion disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine physical therapy+ Sensorimotor stimulationGustatory, 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 | Other | Routine physical therapy + Sensorimotor stimulation |
| Routine physical therapyActive and passive Range of motion exercise of upper and lower limb, Transfer from bed to chair, Sit to stand practice | Other | Routine physical therapy, Routine physical therapy + Sensorimotor stimulation |
Primary outcome
Balance
Time frame: 16th week
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
Time frame: 16th week
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,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Background: PubMed 28124982Nizamutdinov D, Shapiro LA. Overview of Traumatic Brain Injury: An Immunological Context. Brain Sci. 2017 Jan 23;7(1):11. doi: 10.3390/brainsci7010011.
- Background: PubMed 32035565Capizzi 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.
- Background: PubMed 28135424Swanson 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.
- Background: PubMed 26679234Finch 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.
- Individual participant dataSharing planned: No
Related trials for Mild Traumatic Brain Injury
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
Enrolling by invitation
Risk Assessment of Mild Traumatic Brain Injury in Military Training
Trauma, Brain
Not yet recruiting
Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
Concussion (Diagnosis), Gait Abnormality
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huma Waqar, MS PTN* principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine physical therapy+ Sensorimotor stimulation and Routine physical therapy in people with Mild Traumatic Brain Injury, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Haider Ullah Khan, MS PTN (03314127210, haiderullah@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 16th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05194644, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.