- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07935382
Effect of PNF + Core Strengthening Exercise in Sub-acute Guillain Barre Syndrome ( PNF-CORE-GBS ) (PNF-CORE-GBS)
Proprioceptive Neuromuscular Facilitation Combined With Core Strengthening Exercise in Guillain Barre Syndrome Patients
This randomized controlled trial will evaluate the effectiveness of proprioceptive neuromuscular facilitation combined with core strengthening exercises in Guillain barre syndrome patients .A total of 32 participants aged 18-45 years with clinically diagnosed sub-acute GBS will be allocated into two groups. The intervention group will receive PNF techniques combined with core strengthening exercises, while the control group will receive conventional physiotherapy. Both groups will participate in rehabilitation sessions four times per week for eight weeks.The primary outcomes include balance, muscle strength, and functional independence, assessed using the Berg Balance Scale (BBS), Manual Muscle Testing (MMT), and Barthel Index (BI), respectively. Assessments will be conducted at baseline, the fourth week, and the eighth week.The study purpose to determine whether combining PNF with core strengthening exercises provides additional benefits in improving rehabilitation outcomes in patients with sub-acute Guillain-Barré Syndrome.
Study Overview
Status
Conditions
Detailed Description
Guillain-Barré Syndrome (GBS) is an acute immune-mediated inflammatory polyneuropathy characterized by rapidly progressive muscle weakness, diminished or absent deep tendon reflexes, sensory disturbances, impaired balance, and functional limitations in activities of daily living (ADLs). Although most patients recover gradually following the acute phase, many continue to experience persistent muscle weakness, impaired postural control, reduced trunk stability, and decreased functional independence during the subacute stage. Early rehabilitation plays a vital role in maximizing neurological recovery and improving functional outcomes. Conventional physiotherapy is considered a standard rehabilitation approach for patients with subacute GBS and typically includes range of motion exercises, muscle strengthening, balance training, gait training, and functional mobility exercises. However, there is limited evidence regarding the additional benefits of combining Proprioceptive Neuromuscular Facilitation (PNF) with core strengthening exercises in this population. Proprioceptive Neuromuscular Facilitation (PNF) is a therapeutic approach that uses proprioceptive stimulation, resistance, stretching, and coordinated movement patterns to facilitate neuromuscular activation and functional movement. Core strengthening exercises focus on improving trunk stability, pelvic control, postural alignment, and balance.
Although both interventions are used in neurological rehabilitation, evidence regarding the combined application of PNF and core strengthening exercises in patients with sub-acute GBS remains limited. Therefore, this study is designed to evaluate the effectiveness of combining these interventions compared with conventional physiotherapy.
This study is a randomized controlled trial involving 32 participants with clinically diagnosed sub-acute Guillain-Barré Syndrome. Participants will be recruited through non-probability purposive sampling from the Neuro-Medicine Ward and Physiotherapy Outpatient Department of Jinnah Postgraduate Medical Centre (JPMC), Karachi, Pakistan.
Eligible participants will be adults aged 18-45 years, of either gender, diagnosed with GBS and clinically stable for participation in physiotherapy rehabilitation. Participants will be randomly allocated into two groups using the sealed-envelope method. The outcome assessor will be blinded to group allocation.
Participants assigned to Group A will receive Proprioceptive Neuromuscular Facilitation (PNF) combined with core strengthening exercises.
The PNF intervention will include Contract-Relax (CR) and Contract-Relax-Antagonist-Contract (CRAC) techniques applied to the upper and lower extremities. The techniques will involve an initial stretch of approximately 10-20 seconds, followed by resisted muscle contraction lasting 3-6 seconds, with a relaxation period of approximately 2-3 seconds before further stretching.
Core strengthening exercises will include:
- Pelvic control exercises.
- Bridging exercises.
- Curl-up exercises.
- Curl-ups with diagonal reaching.
- Bridging with crossed legs.
- Single-leg bridging.
- Side-bridging exercises. These exercises will target trunk and pelvic stability, neuromuscular control, and postural function.
*Control Group (Group B)*
Participants assigned to Group B will receive conventional physiotherapy, including:
- Upper and lower extremity stretching and strengthening exercises.
- Techniques for normalization of muscle tone.
- Weight-bearing exercises.
- Active functional training.
- Postural control exercises.
- Conventional balance training. Both groups will receive physiotherapy rehabilitation four times per week over eight weeks.
The study will evaluate the following outcome measures:
- Balance: Assessed using the Berg Balance Scale (BBS), which evaluates static and dynamic balance through 14 functional tasks. The total score ranges from 0 to 56.
- Muscle Strength: Assessed using Manual Muscle Testing (MMT), which evaluates muscle strength on a grading scale from 0 to 5.
- Functional Independence: Assessed using the Barthel Index (BI), which evaluates independence in activities of daily living, including feeding, bathing, dressing, transfers, mobility, and stair climbing. The total score ranges from 0 to 100.
Assessments will be performed at baseline, the fourth week, and the eighth week of the intervention.
The primary objective is to determine whether PNF combined with core strengthening exercises is more effective than conventional physiotherapy in improving balance, muscle strength, and functional independence among patients with sub-acute Guillain-Barré Syndrome.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rida Rao, MSPTN
- Phone Number: 03153515825
- Email: ridarao201@gmail.com
Study Contact Backup
- Name: kanwal Mirani, MSPTN
- Phone Number: 03123474874
- Email: kanwalmiranikanwalmirani33@gmail.com
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- University of Lahore teaching hospital, Lahore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- participants diagnosed with Guillain Barré Syndrome (GBS) based on neurological criteria
- At the subacute or recovery stage of GBS, meaning within two to 12 weeks from disease onset
- Age ranges from 18 to 45 years
- Gender does not matter; both males and females can participate
- Medical stability of the patient and being medically cleared to engage in intensive rehabilitation by a physical Ability to give informed consent
Exclusion Criteria:•Patients with cognitive disabilities and those who cannot follow commands
- Patients with unstable heart and breathing rates and other systemic disease
- Patients refusing to give their informed consent
- Presence of musculoskeletal problems with balance problems (recent fractures, arthritis)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PNF+Core strengthening Group
Participants in the experimental group will receive Proprioceptive Neuromuscular Facilitation (PNF) combined with core strengthening exercises versus conventional physiotherapy. The intervention will be administered according to the study protocol over 4 times in week for 8-week period. |
Participants in the experimental group will receive PNF techniques, including Contract-Relax (CR) and Contract-Relax-Antagonist-Contract (CRAC), applied to the upper and lower extremities. The intervention will involve an initial stretch of 10-20 seconds, followed by resisted muscle contraction lasting 3-6 seconds, with approximately 2-3 seconds of rest between contractions and subsequent stretching. PNF will be combined with core strengthening exercises during the 8-week rehabilitation program. Participants in the experimental group will perform core strengthening exercises targeting trunk and pelvic stability. Exercises will include pelvic control exercises, bridging, curl-ups, curl-ups with diagonal reaching, bridging with crossed legs, single-leg bridging, and side bridging. These exercises will be administered in combination with PNF techniques over an 8-week rehabilitation program. |
|
Active Comparator: conventional physiotheraphy Group
conventional physical therapy Participants in the control group will receive conventional physiotherapy according to the standard rehabilitation protocol for patients with subacute Guillain-Barré Syndrome over 4 time per week for 8 week period |
Participants in the control group will receive conventional physiotherapy, including stretching and strengthening exercises for the upper and lower extremities, muscle tone normalization techniques, weight-bearing exercises, active functional training, postural control exercises, and conventional balance training. Treatment will be provided four times per week for eight weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: Baseline , week 4 and week 8
|
Balance was assessed using the Berg Balance Scale (BBS) . The Berg Balance Scale is a 14-item clinical scale that measures static and dynamic balance. Scores range from 0 to 56, with higher scores indicating better balance and functional performance |
Baseline , week 4 and week 8
|
|
muscle strength
Time Frame: Baseline, week 4 and week 8
|
Muscle strength was assessed using the Medical Research Council (MRC) Manual Muscle Testing scale. Muscle strength is graded from 0 to 5, where 0 indicates no muscle contraction and 5 indicates normal muscle strength. Higher scores indicate better muscle strength. |
Baseline, week 4 and week 8
|
|
Activities of Daily living (ADL)
Time Frame: Baseline , week 4 and week 8
|
Activities of daily living were assessed using the Barthel Index (BI). The Barthel Index measures independence in activities of daily living. Scores range from 0 to 100, with higher scores indicating greater functional independence. |
Baseline , week 4 and week 8
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- Nervous System Diseases
- Pathologic Processes
- Neuromuscular Diseases
- Chronic Disease
- Disease Attributes
- Autoimmune Diseases
- Immune System Diseases
- Peripheral Nervous System Diseases
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Polyneuropathies
- Polyradiculoneuropathy
- Pathological Conditions, Signs and Symptoms
- Guillain-Barre Syndrome
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Exercise
- Muscle Stretching Exercises
Other Study ID Numbers
- UOL/IREB/26/19/01/0017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.