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

• ClinicalTrials.gov Identifier: NCT05957731
• Recruitment Status: Completed
• First Posted: July 24, 2023
• Last Update Posted: August 3, 2023
• Sponsor: University of Lahore
• Information provided by (Responsible Party): University of Lahore

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.

Condition or disease	Intervention/treatment	Phase
Stroke	Other: Routine physical therapy; Other: antagonist contract relax; Other: agonist contract relax	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Agonist Contract Relax Versus Antagonist Contract Relax Technique on Spasticity and Ankle Range of Motion in Chronic Stroke Patient.
• Actual Study Start Date: November 7, 2022
• Actual Primary Completion Date: July 30, 2023
• Actual Study Completion Date: July 30, 2023

Arms and Interventions

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 Name: 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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Pakistan

sir Ganga Raam hospital lahore

Lahore, Pakistan

univerity of Lahore teaching hopital

Lahore, Pakistan

Sponsors and Collaborators

University of Lahore

More Information

• Responsible Party: University of Lahore
• ClinicalTrials.gov Identifier: NCT05957731
• Other Study ID Numbers: REC-UOL-246-04-2023
• First Posted: July 24, 2023
• Last Update Posted: August 3, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Lahore:

Stroke; Agonist contract relax; antagonist contract relax; stretching; modified A

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases