Back to resultsEffects of Core Strengthening and PNF Pattern on Balance and Plantar Pressure in Chronic Stroke (PNF)
Primary Purpose
Stroke; Paralysis
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
core strengthening exercises
Routine physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke; Paralysis focused on measuring Stroke, Static Balance, PNF, Plantar Pressure, PoData
Eligibility Criteria
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.
Sites / Locations
- The University of Lahore Teaching HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group A
Group B
Arm Description
• 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 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
Outcomes
Primary Outcome Measures
Static Standing balance
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
Secondary Outcome Measures
Plantar pressure
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05436782
Brief Title
Effects of Core Strengthening and PNF Pattern on Balance and Plantar Pressure in Chronic Stroke
Acronym
PNF
Official Title
Effects of Core Strengthening and Proprioceptive Neuromuscular Facilitation Pattern on Static Standing Balance and Plantar Pressure in Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
August 14, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lahore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the effects of core strengthening and PNF on standing balance and plantar pressure in chronic stroke patients
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke; Paralysis
Keywords
Stroke, Static Balance, PNF, Plantar Pressure, PoData
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
73 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
• 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
Arm Title
Group B
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
core strengthening exercises
Intervention Description
•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
Intervention Type
Other
Intervention Name(s)
Routine physical therapy
Intervention Description
•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
Primary Outcome Measure Information:
Title
Static Standing balance
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Plantar pressure
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sameed Liaqat, DPT
Phone
0324 9004200
Email
samiliaqat3@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameed Liaqat, DPT
Organizational Affiliation
The University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Lahore Teaching Hospital
City
Lahore
State/Province
Punjqb
ZIP/Postal Code
40050
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wardah Rauf, MSPTN
Phone
03374915954
Email
wardahrauf99@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Core Strengthening and PNF Pattern on Balance and Plantar Pressure in Chronic Stroke
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