NCT05491096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

July 14, 2022

Last Update Submit

July 31, 2023

Conditions

Keywords

Guillain Barre SyndromeProprioceptive Neuromuscular TrainingBalanceMotor FunctionSensory Function

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Proprioceptive Neuromuscular Training

EXPERIMENTAL

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

Conventional Physical Therapy

PLACEBO COMPARATOR

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

Interventions

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.

Proprioceptive Neuromuscular Training

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.

Conventional Physical Therapy

Eligibility Criteria

Age10 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

psrd (pakistan Society for the rehabilitation of the disabled)

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sara Aabroo

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2022

First Posted

August 8, 2022

Study Start

June 5, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations