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

July 31, 2023 updated by: Riphah International University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • psrd (pakistan Society for the rehabilitation of the disabled)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Berg Balance Scale
Time Frame: 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.
12th Week
Time up and go test
Time Frame: 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.
12th Week
One leg stance test
Time Frame: 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.
12th Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sara Aabroo, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/22/0219 Salma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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