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

Primary Purpose

Guillain-Barre Syndrome

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Proprioceptive Neuromuscular Training
Conventional Physical Therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Guillain-Barre Syndrome focused on measuring Guillain Barre Syndrome, Proprioceptive Neuromuscular Training, Balance, Motor Function, Sensory Function

Eligibility Criteria

10 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • psrd (pakistan Society for the rehabilitation of the disabled)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Proprioceptive Neuromuscular Training

Conventional Physical Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2022
Last Updated
July 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05491096
Brief Title
Effects of Proprioceptive Neuromuscular Training on Sensory and Motor Function in Guillain Barre Syndrome
Official Title
Comparison of Effects of Proprioceptive Neuromuscular Training on Sensory Versus Motor Function in Patients With Guillain Barre Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 5, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Guillain-Barre Syndrome
Keywords
Guillain Barre Syndrome, Proprioceptive Neuromuscular Training, Balance, Motor Function, Sensory Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proprioceptive Neuromuscular Training
Arm Type
Experimental
Arm Description
It consists of 13 patients who will receive conventional exercises and proprioceptive training with 2 sessions per week for 8 weeks.
Arm Title
Conventional Physical Therapy
Arm Type
Placebo Comparator
Arm Description
It consists of 13 patients who will receive conventional exercises i.e; strengthening exercises, 2 sessions per week for 8 weeks
Intervention Type
Other
Intervention Name(s)
Proprioceptive Neuromuscular Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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 Frame
12th Week
Title
Time up and go test
Description
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.
Time Frame
12th Week
Title
One leg stance test
Description
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.
Time Frame
12th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Aabroo
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
psrd (pakistan Society for the rehabilitation of the disabled)
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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