StrokeNCT05957731
Effect of Agonist Contract Relax Versus Antagonist Contract Relax in Chronic Stroke Patient.
A study testing Routine physical therapy, antagonist contract relax and agonist contract relax in people with Stroke, run by University of Lahore at 2 sites in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Routine physical therapy, antagonist contract relax and agonist contract relax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesPakistan
- Study dates
- 7 Nov 2022to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- History of surgery on lower limb
- Who received injection therapies for reducing spasticity
- Lower extremity contracture
- Modified Ashworth scale of 3-4
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
sir Ganga Raam hospital lahore
Lahore
univerity of Lahore teaching hopital
Lahore
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Routine physical therapy, antagonist contract relax, agonist contract relax
- Keywords
- Stroke, Agonist contract relax, antagonist contract relax, stretching, modified A
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine physical therapyOther
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 relaxOther
antagonist contraction i used to improve spasticity and range of motion in stroke patients
agonist contract relaxOther
Also called agonist contraction
agonist contraction is used to improve spasticity and range of motion in stroke patients
| Study group | Role | What they receive |
|---|---|---|
| Agonist Contract-relax group: | Experimental | 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. Receives: Other: Routine physical therapy; Other: agonist contract relax |
| Antagonist contract-relax group: | Experimental | 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. Receives: Other: Routine physical therapy; Other: antagonist contract relax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: it will measure change in spasticity at baseline and at 8th week
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.
Measured: it will measure change in range of motion at baseline and at 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start7 Nov 2022
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957731
- Sponsor's protocol ID
- REC-UOL-246-04-2023
- Status last verified
- Aug 2023
- First submitted
- 15 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Agonist Contract Relax Versus Antagonist Contract Relax Technique on Spasticity and Ankle Range of Motion in Chronic Stroke Patient.
- ClinicalTrials.gov ID
- NCT05957731
- Acronym / sponsor ID
- REC-UOL-246-04-2023
- Conditions
- Stroke
- Keywords
- Stroke, Agonist contract relax, antagonist contract relax, stretching, modified A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Agonist Contract-relax group: | Experimental | Other: Routine physical therapy, Other: agonist contract relaxIn 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. |
| Antagonist contract-relax group: | Experimental | Other: Routine physical therapy, Other: antagonist contract relaxIn 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- History of surgery on lower limb
- Who received injection therapies for reducing spasticity
- Lower extremity contracture
- Modified Ashworth scale of 3-4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine physical therapyBoth 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 group:, Antagonist contract-relax group: |
| antagonist contract relaxantagonist contraction i used to improve spasticity and range of motion in stroke patients | Other | Antagonist contract-relax group: |
| agonist contract relaxAlso: agonist contractionagonist contraction is used to improve spasticity and range of motion in stroke patients | Other | Agonist Contract-relax group: |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine physical therapy, antagonist contract relax and agonist contract relax in people with Stroke, run by University of Lahore at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale. (time frame: it will measure change in spasticity at baseline and at 8th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.