- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05436782
Effects of Core Strengthening and PNF Pattern on Balance and Plantar Pressure in Chronic Stroke (PNF)
June 23, 2022 updated by: University of Lahore
Effects of Core Strengthening and Proprioceptive Neuromuscular Facilitation Pattern on Static Standing Balance and Plantar Pressure in Chronic Stroke
To compare the effects of core strengthening and PNF on standing balance and plantar pressure in chronic stroke patients
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The effects of different exercise regimes and PNF techniques on balance and plantar pressure had been studied.
This study focuses on determining the effects of CSE and PNF techniques on developing static standing balance and plantar pressure in stroke patients using PoData
Study Type
Interventional
Enrollment (Anticipated)
73
Phase
- 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 Contact
- Name: Sameed Liaqat, DPT
- Phone Number: 0324 9004200
- Email: samiliaqat3@gmail.com
Study Locations
-
-
Punjqb
-
Lahore, Punjqb, Pakistan, 40050
- Recruiting
- The University of Lahore Teaching Hospital
-
Contact:
- Wardah Rauf, MSPTN
- Phone Number: 03374915954
- Email: wardahrauf99@gmail.com
-
-
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
Ages Eligible for Study
45 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Age 45-60
- Score of 9 or higher on the static component of Berg Balance Scale
- Both genders will be recruited.
- First ever episode of stroke
- Duration of stroke greater than 6 months.
- Having a score of equal to or less than 2 on the Modified Ashworth Scale
- Having a score of greater than or equal to 24 on the Mini-mental state examination in order to understand the commands.
Exclusion Criteria:
• Concurrent orthopedic (for e.g. amputation ) that may hamper standing
- Relevant psychiatric disorders that may prevent from following instructions.
- Other medical drugs that may influence our intervention
- Condition contraindicating physical activity
- Use of cardiac pacemakers.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A
• Group A (control group) will receive routine physical therapy involving muscle strengthening exercises, range of motion exercises, and stretching exercises up to the patient's tolerance.
Other exercises will be pelvic bridging, rolling, sitting and standing exercises, walking practice and balancing in parallel bars, and wobble board exercises.
Each session will be of 60 minutes 5 times weekly for 6 weeks
|
•Group A (control group) will receive routine physical therapy involving muscle strengthening exercises, range of motion exercises, and stretching exercises up to the patient's tolerance.
Other exercises were pelvic bridging, rolling, sitting and standing exercises, walking practice and balancing in parallel bars, and wobble board exercises.
Each session was of 60 minutes 5 times weekly for 6 weeks
|
|
Experimental: Group B
Group B (experimental group) will receive routine physical therapy for 20 minutes and additionally PNF technique (rhythmic initiation, and then agonistic reversals will be performed in lower extremity in D1 flexion pattern and D1 extension pattern up to patient's tolerance and core strengthening for 20 minutes 5 times weekly for 6 weeks.
The outcome measure will be measured at and 6th week interval
|
•Group B (experimental group) received routine physical therapy for 20 minutes and additionally PNF technique (rhythmic initiation, and then agonistic reversals were performed in the lower extremity in D1 flexion pattern and D1 extension pattern up to the patient's tolerance and core strengthening for 20 minutes 5 times weekly for 6 weeks.
The outcome measure was measured at baseline and 6th-week interval
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Static Standing balance
Time Frame: 6 months
|
It is measured using static component of berg balance scale.
The items are scored from 0 to 4, with a score of 0 representing an inability to complete the task and a score of 4 representing independent item completion.
Static component score is calculated out of 24 possible points.
Scores of 0 to 9 represent static balance impairment, 10 to 15 represent acceptable static balance, and 15 to 24 represent good static balance
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plantar pressure
Time Frame: 6 months
|
PoData (Chinesport, Italy Version 5.0) this system provides information about weight distribution by measuring total body weight on fifth, first metatarsal and heel For a healthy individual the normal distribution is as follows 16.67% of the total body weight on the fifth metatarsal head, 33.33% of the total body weight on first metatarsal.
50% of the total body weight on heel
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sameed Liaqat, DPT, The University of Lahore
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)
December 3, 2021
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
August 14, 2022
Study Registration Dates
First Submitted
June 23, 2022
First Submitted That Met QC Criteria
June 23, 2022
First Posted (Actual)
June 29, 2022
Study Record Updates
Last Update Posted (Actual)
June 29, 2022
Last Update Submitted That Met QC Criteria
June 23, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-UOL-FAHS/1089/2021
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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