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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05957731
Other study ID # REC-UOL-246-04-2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 7, 2022
Est. completion date July 30, 2023

Study information

Verified date August 2023
Source University of Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date July 30, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
antagonist contract relax
antagonist contraction i used to improve spasticity and range of motion in stroke patients
agonist contract relax
agonist contraction is used to improve spasticity and range of motion in stroke patients

Locations

Country Name City State
Pakistan sir Ganga Raam hospital lahore Lahore
Pakistan univerity of Lahore teaching hopital Lahore

Sponsors (1)

Lead Sponsor Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. it will measure change in spasticity at baseline and at 8th week
Primary 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. it will measure change in range of motion at baseline and at 8th week
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