Effects of Proprioceptive Neuromuscular Training on Sensory and Motor Function in Guillain Barre Syndrome

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05491096

Collaborator

(none)

Enrollment

Location

Arms

2.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Guillain-Barre Syndrome	Other: Proprioceptive Neuromuscular Training Other: Conventional Physical Therapy	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Effects of Proprioceptive Neuromuscular Training on Sensory Versus Motor Function in Patients With Guillain Barre Syndrome

Actual Study Start Date :

Jun 5, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Proprioceptive Neuromuscular Training It consists of 13 patients who will receive conventional exercises and proprioceptive training with 2 sessions per week for 8 weeks.	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.
Placebo Comparator: Conventional Physical Therapy It consists of 13 patients who will receive conventional exercises i.e; strengthening exercises, 2 sessions per week for 8 weeks	Other: 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.

Arm

Intervention/Treatment

Experimental: Proprioceptive Neuromuscular Training

It consists of 13 patients who will receive conventional exercises and proprioceptive training with 2 sessions per week for 8 weeks.

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.

Placebo Comparator: Conventional Physical Therapy

It consists of 13 patients who will receive conventional exercises i.e; strengthening exercises, 2 sessions per week for 8 weeks

Other: 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.

Outcome Measures

Primary Outcome Measures

Berg Balance Scale [12th Week]
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.
Time up and go test [12th Week]
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.
One leg stance test [12th Week]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed with Guillain Barre Syndrome already taking treatments
Inflammatory Demyelinating Guillain Barre Syndrome patients
Acute motor sensory axonal neuropathy
Guillain Barre Syndrome patients in the subacute phase
Guillain Barre Syndrome patients with impaired proprioception
Patients with Glasgow Coma Scale above 12

Exclusion Criteria:

Other Guillain Barre Syndrome types
Spinal cord injury
Traumatic neuritis
Not Fulfilling Above Criteria Of Age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	psrd (pakistan Society for the rehabilitation of the disabled)	Lahore	Punjab	Pakistan	54000

Sponsors and Collaborators

Riphah International University

Investigators

Principal Investigator: Sara Aabroo, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT05491096

Other Study ID Numbers:

REC/22/0219 Salma

First Posted:

Aug 8, 2022

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

Guillain Barre Syndrome

Proprioceptive Neuromuscular Training

Balance

Motor Function

Sensory Function

Additional relevant MeSH terms:

Guillain-Barre Syndrome

Syndrome

Study Results

No Results Posted as of Aug 8, 2022