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Effect of Agonist Contract Relax Versus Antagonist Contract Relax in Chronic Stroke Patient.

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Routine physical therapy
antagonist contract relax
agonist contract relax
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Agonist contract relax, antagonist contract relax, stretching, modified A

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with a confirmed diagnosis of stroke by a neurologist. Inclusion of patients with both ischemic and hemorrhagic stroke. Both male and female patients are eligible. Age range between 40 to 60 years. Modified Ashworth Scale ranging from 0 to 2. Minimum muscle strength grade of 3 Exclusion Criteria: History of surgery on lower limb Who received injection therapies for reducing spasticity Lower extremity contracture Modified Ashworth scale of 3-4

Sites / Locations

  • sir Ganga Raam hospital lahore
  • univerity of Lahore teaching hopital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Agonist Contract-relax group:

Antagonist contract-relax group:

Arm Description

In the agonist contract-relax group, participants were positioned in a supine position. A trained physiotherapist then passively dorsiflexed the ankle to its maximum available range and held it for 15 seconds, while ensuring that the knee remained straight by placing a hand on it. Following this, participants were instructed to perform a maximal voluntary isometric 35 contraction of the planter flexors for five seconds, while maintaining the stretched position. After a 30-second rest period, the physiotherapist returned the ankle to the starting position of 0 degrees and repeat the procedure without any rest. This stretching protocol was repeated four times, with each repetition lasting 2 minutes. For the soleus muscles, the same procedure was performed, but with a slightly flexed initial position of the knee.

In the antagonist stretching groups, participants were positioned in a supine position. A trained physiotherapist stretched the antagonist's muscle, and then participants were instructed to perform a maximal voluntary isometric contraction of dorsiflexion for 5 seconds while maintaining a stretched position. The knee was kept straight during this contraction. Following the contraction, the physiotherapist held the ankle at that angle for another 10 seconds by placing a hand on it. After a 30-second rest period, the physiotherapist returned the ankle to the starting position of 0 degrees and repeat the procedure without any rest intervals.

Outcomes

Primary Outcome Measures

Modified Ashworth Scale.
The assessment involves extending the limb of the parent from a state of utmost flexion to utmost extension, identifying the point at which initial mild resistance was encountered. Following that, the modified Ashworth Scale is employed while transitioning the limb from extension to flexion. Interrater reliability studies utilizing the MAS have yielded varied results, ranging from moderate to good.
universal goniometer
The universal goniometer (UG) is a widely employed tool for assessing range of motion.Range of motion refers to the complete extent of movement possible at a specific joint. In a normal ankle, the range of motion typically spans from around 20ºof dorsiflexion to 50º of plantar flexion. For normal walking, a combined motion of approximately 24º to 30º (including both dorsiflexion and plantar flexion) is required.

Secondary Outcome Measures

Full Information

First Posted
July 15, 2023
Last Updated
August 1, 2023
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05957731
Brief Title
Effect of Agonist Contract Relax Versus Antagonist Contract Relax in Chronic Stroke Patient.
Official Title
Effect of Agonist Contract Relax Versus Antagonist Contract Relax Technique on Spasticity and Ankle Range of Motion in Chronic Stroke Patient.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
July 30, 2023 (Actual)

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
Yes

5. Study Description

Brief Summary
It will be a randomized control trial with 112 patients which will be divided into two groups of 56 patients in each group. Participants will recruit through convenient sampling techniques. Outcome measures are range of motion and spasticity. The protocol was implemented three days per week for eight consecutive weeks. Data will be collected at baseline and 8 th week after intervention.
Detailed Description
Objective of the study is to compare the effects of the agonist contract-relax technique versus the antagonist contract-relax technique on spasticity and range of motion in individuals with chronic stroke. Null hypothesis (H0): There are no comparative effects of agonist contact-relax technique and the antagonist contract-relax technique on spasticity and ankle range of motion in chronic patients. The alternate hypothesis (HA): There are comparative effects of agonist contract-relax technique and the antagonist contract-relax technique on spasticity and ankle range of motion in chronic stroke patients. The sample size came out to 94 (47 in each group) after adding 20% dropout the sample size was 47+9=56 in each group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Agonist contract relax, antagonist contract relax, stretching, modified A

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Agonist Contract-relax group:
Arm Type
Experimental
Arm Description
In the agonist contract-relax group, participants were positioned in a supine position. A trained physiotherapist then passively dorsiflexed the ankle to its maximum available range and held it for 15 seconds, while ensuring that the knee remained straight by placing a hand on it. Following this, participants were instructed to perform a maximal voluntary isometric 35 contraction of the planter flexors for five seconds, while maintaining the stretched position. After a 30-second rest period, the physiotherapist returned the ankle to the starting position of 0 degrees and repeat the procedure without any rest. This stretching protocol was repeated four times, with each repetition lasting 2 minutes. For the soleus muscles, the same procedure was performed, but with a slightly flexed initial position of the knee.
Arm Title
Antagonist contract-relax group:
Arm Type
Experimental
Arm Description
In the antagonist stretching groups, participants were positioned in a supine position. A trained physiotherapist stretched the antagonist's muscle, and then participants were instructed to perform a maximal voluntary isometric contraction of dorsiflexion for 5 seconds while maintaining a stretched position. The knee was kept straight during this contraction. Following the contraction, the physiotherapist held the ankle at that angle for another 10 seconds by placing a hand on it. After a 30-second rest period, the physiotherapist returned the ankle to the starting position of 0 degrees and repeat the procedure without any rest intervals.
Intervention Type
Other
Intervention Name(s)
Routine physical therapy
Intervention Description
Both groups received routine physical therapy, which encompasses various components such as electrotherapy, strength training for both lower and upper limbs, gait training, and occupational therapy.
Intervention Type
Other
Intervention Name(s)
antagonist contract relax
Intervention Description
antagonist contraction i used to improve spasticity and range of motion in stroke patients
Intervention Type
Other
Intervention Name(s)
agonist contract relax
Other Intervention Name(s)
agonist contraction
Intervention Description
agonist contraction is used to improve spasticity and range of motion in stroke patients
Primary Outcome Measure Information:
Title
Modified Ashworth Scale.
Description
The assessment involves extending the limb of the parent from a state of utmost flexion to utmost extension, identifying the point at which initial mild resistance was encountered. Following that, the modified Ashworth Scale is employed while transitioning the limb from extension to flexion. Interrater reliability studies utilizing the MAS have yielded varied results, ranging from moderate to good.
Time Frame
it will measure change in spasticity at baseline and at 8th week
Title
universal goniometer
Description
The universal goniometer (UG) is a widely employed tool for assessing range of motion.Range of motion refers to the complete extent of movement possible at a specific joint. In a normal ankle, the range of motion typically spans from around 20ºof dorsiflexion to 50º of plantar flexion. For normal walking, a combined motion of approximately 24º to 30º (including both dorsiflexion and plantar flexion) is required.
Time Frame
it will measure change in range of motion at baseline and at 8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a confirmed diagnosis of stroke by a neurologist. Inclusion of patients with both ischemic and hemorrhagic stroke. Both male and female patients are eligible. Age range between 40 to 60 years. Modified Ashworth Scale ranging from 0 to 2. Minimum muscle strength grade of 3 Exclusion Criteria: History of surgery on lower limb Who received injection therapies for reducing spasticity Lower extremity contracture Modified Ashworth scale of 3-4
Facility Information:
Facility Name
sir Ganga Raam hospital lahore
City
Lahore
Country
Pakistan
Facility Name
univerity of Lahore teaching hopital
City
Lahore
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Agonist Contract Relax Versus Antagonist Contract Relax in Chronic Stroke Patient.

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