NCT05957731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

July 15, 2023

Last Update Submit

August 1, 2023

Conditions

Keywords

StrokeAgonist contract relaxantagonist contract relaxstretchingmodified A

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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.

Other: Routine physical therapyOther: 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.

Other: Routine physical therapyOther: antagonist contract relax

Interventions

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.

Agonist Contract-relax group:Antagonist contract-relax group:

antagonist contraction i used to improve spasticity and range of motion in stroke patients

Antagonist contract-relax group:

agonist contraction is used to improve spasticity and range of motion in stroke patients

Also known as: agonist contraction
Agonist Contract-relax group:

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with a confirmed diagnosis of stroke by a neurologist.
  • 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

You may not qualify if:

  • History of surgery on lower limb
  • Who received injection therapies for reducing spasticity
  • Lower extremity contracture
  • Modified Ashworth scale of 3-4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

sir Ganga Raam hospital lahore

Lahore, Pakistan

Location

univerity of Lahore teaching hopital

Lahore, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2023

First Posted

July 24, 2023

Study Start

November 7, 2022

Primary Completion

July 30, 2023

Study Completion

July 30, 2023

Last Updated

August 3, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations