Guillain-Barre SyndromeNCT05491096
Effects of Proprioceptive Neuromuscular Training on Sensory and Motor Function in Guillain Barre Syndrome
A study testing Proprioceptive Neuromuscular Training and Conventional Physical Therapy in people with Guillain-Barre Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study aims to determine the effects of Proprioceptive Neuromuscular Training on Sensory versus Motor Function in patients presenting with Guillain Barre Syndrome. Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Guillain-Barre Syndrome
- What is being tested?
- Proprioceptive Neuromuscular Training and Conventional Physical Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jun 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Other Guillain Barre Syndrome types
- Spinal cord injury
- Traumatic neuritis
- Not Fulfilling Above Criteria Of Age
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
psrd (pakistan Society for the rehabilitation of the disabled)
Lahore, Punjab Province, 54000
About this study
Official title: 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.
Read the 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.
- Conditions
- Guillain-Barre Syndrome
- Being tested
- Proprioceptive Neuromuscular Training, Conventional Physical Therapy
- Keywords
- Guillain Barre Syndrome, Proprioceptive Neuromuscular Training, Balance, Motor Function, Sensory Function
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular TrainingOther
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.
Conventional Physical TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start5 Jun 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain-Barre SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Aabroo, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491096
- Sponsor's protocol ID
- REC/22/0219 Salma
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Proprioceptive Neuromuscular Training on Sensory Versus Motor Function in Patients With Guillain Barre Syndrome
- ClinicalTrials.gov ID
- NCT05491096
- Acronym / sponsor ID
- REC/22/0219 Salma
- Conditions
- Guillain-Barre Syndrome
- Keywords
- Guillain Barre Syndrome, Proprioceptive Neuromuscular Training, Balance, Motor Function, Sensory Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive Neuromuscular Training | Experimental | Other: Proprioceptive Neuromuscular TrainingIt consists of 13 patients who will receive conventional exercises and proprioceptive training with 2 sessions per week for 8 weeks. |
| Conventional Physical Therapy | Placebo comparator | Other: Conventional Physical TherapyIt consists of 13 patients who will receive conventional exercises i.e; strengthening exercises, 2 sessions per week for 8 weeks |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Other Guillain Barre Syndrome types
- Spinal cord injury
- Traumatic neuritis
- Not Fulfilling Above Criteria Of Age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive Neuromuscular TrainingProprioceptive 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. | Other | Proprioceptive Neuromuscular Training |
| Conventional Physical TherapyConventional 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. | Other | Conventional Physical Therapy |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Aabroo principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Neuromuscular Training and Conventional Physical Therapy in people with Guillain-Barre Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 12th Week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.