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

August 1, 2023 updated by: University of Lahore

Effect of Agonist Contract Relax Versus Antagonist Contract Relax Technique on Spasticity and Ankle Range of Motion in Chronic Stroke Patient.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

112

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 Locations

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

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

  • Adult

Accepts Healthy Volunteers

No

Description

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

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
Experimental: Agonist Contract-relax group:

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.
Other: Routine physical therapy
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.
Other: agonist contract relax
agonist contraction is used to improve spasticity and range of motion in stroke patients
Other Names:
  • agonist contraction
Experimental: Antagonist contract-relax group:

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.
Other: Routine physical therapy
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.
Other: antagonist contract relax
antagonist contraction i used to improve spasticity and range of motion in stroke patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale.
Time Frame: it will measure change in spasticity at baseline and at 8th week
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.
it will measure change in spasticity at baseline and at 8th week
universal goniometer
Time Frame: it will measure change in range of motion at baseline and at 8th week
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.
it will measure change in range of motion at baseline and at 8th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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)

November 7, 2022

Primary Completion (Actual)

July 30, 2023

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

July 15, 2023

First Submitted That Met QC Criteria

July 15, 2023

First Posted (Actual)

July 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-UOL-246-04-2023

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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