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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05491096
Other study ID # REC/22/0219 Salma
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 5, 2022
Est. completion date February 28, 2023

Study information

Verified date July 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to determine the effects of Proprioceptive Neuromuscular Training on Sensory versus Motor Function in patients presenting with Guillain Barre Syndrome.


Description:

This study will be a randomized controlled trial and will be conducted to determine the effects of proprioceptive neuro-muscular training on sensory and motor function of lower limb,In this study data will be collected from multiple Hospitals of Lahore via Berg Balance Scale, Timed Up and Go test One Leg Stance test before and after intervention. Non- probability convenient sampling technique will be used to enroll 26 patients in total. The patients will be randomly allocated into two groups through lottery method, to either the proprioceptive training group or control group.Both groups will be assessed for proprioception via lower extremity position test as a baseline. Proprioception training programme will be implemented in experimental group and will be carried out for eight weeks, with three (60-minute) sessions per week. It will start with 10 minutes of Warm-up. This will be followed by 30 minutes of proprioceptive exercises targeting lower extremities. Proprioceptive exercises will be divided into three components, standing on Foam with eyes open and eyes closed and passing any object from one subject to the other for 10 minutes, throwing and catching a ball will be performed while standing on foam for additional 10 minutes, throwing and catching a ball, will be performed on trampoline to further challenge the balance system. After each set of 10-minute exercise, the subjects will be given two-minute resting periods. In the end, 10 minutes will be given for cool down exercises to bring the heart rate back to resting level. All participants in both groups will be evaluated before and after the treatment programs. Data will be analyzed by using Statistical Package of Social Sciences Version 26.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date February 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 10 Years to 25 Years
Eligibility Inclusion Criteria: 1. Diagnosed with Guillain Barre Syndrome already taking treatments 2. Inflammatory Demyelinating Guillain Barre Syndrome patients 3. Acute motor sensory axonal neuropathy 4. Guillain Barre Syndrome patients in the subacute phase 5. Guillain Barre Syndrome patients with impaired proprioception 6. Patients with Glasgow Coma Scale above 12 Exclusion Criteria: 1. Other Guillain Barre Syndrome types 2. Spinal cord injury 3. Traumatic neuritis 4. Not Fulfilling Above Criteria Of Age

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Proprioceptive Neuromuscular Training
Proprioceptive exercises will be divided into three components. The first component will be comprised of standing on Foam with eyes open and eyes closed and passing any object from one subject to the other for 10 minutes. The second component consists of activity that will be performed in groups of two. Throwing and catching a ball will be performed while standing on foam for additional10 minutes. The third component, throwing and catching a ball, will be performed on trampoline to further challenge the balance system. After each set of 10-minute exercise, the subjects will be given two-minute resting periods. In the end, 10 minutes will be given for cooling down in which deep breathing exercises and static back extensor stretching exercises will be performed to avoid fatigue and to bring the heart rate back to the normal resting level.
Conventional Physical Therapy
Conventional treatment protocolconsists of a structured exercise protocol Each training session consisted of three parts, the first part included the main movements (warming up 10 minutes plus 5 minutes stretching exercises), the second part consisted of specific movements (exercises with theraband and physioball, 20 minutes), and the third part composed of cool down exercises (10 minutes).(22)Experimental treatment protocolwill be proprioceptive training program. PTP will be based on earlier studies, and will be carried out for eight weeks, with two 60-minute sessions per week. It will start with 10 minutes of Warm-up activities when the subjects will be advised to do light manual stretches and to step up and down on foam to get their body warmed up to have improve muscular flexibility. This will be followed by 30 minutes of proprioceptive exercises targeting lower extremities.

Locations

Country Name City State
Pakistan psrd (pakistan Society for the rehabilitation of the disabled) Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Berg Balance Scale The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to completed. 12th Week
Primary Time up and go test It is used to determine fall risk and measure the progress of balance, sit to stand and walking.It is Simple screening test that is a sensitive and specific measure of probability for falls among older adults. 12th Week
Primary One leg stance test The Single leg Stance Test is used to assess static postural and balance control. Balance assessments are a valuable clinical tool for monitoring neurological and musculoskeletal status as well as for managing fall risk. 12th Week
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