Additional Effects of Functional Muscle Training With Turning Based Specific Training During Turning in Post Stroke Patients

December 19, 2024 updated by: Foundation University Islamabad
Stroke is the leading cause of disability leading to Gait and balance dysfunction leading to decreased Quality of Life. Difficulty in turning is a major target in Gait Rehabilitation. Task specific exercises has proven to be effective in all stages of stroke rehabilitation, therefore Turning based specific training is to be used in order to improve turning and balance in post stroke patients moreover functional strength training of lower extremities prove to be more effective than traditional training.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objectives of this study are:

  1. To determine the additional effects of functional muscle training with turning based specific training on turning in Gait among post stroke patients.
  2. To the determine the additional effects of functional muscle training with turning based specific training on balance in post stroke patients.
  3. To determine the additional effects of functional muscle training with turning based specific training on Quality of LIfe aming post stroke patients.

HYPOTHESIS:

Alternate hypothesis 1.1HA-There will be a statistically significant difference of muscle training in addition with turning based specific training in turning among post stroke patients (p<0.05).

2. 2HA- There will be statistically significant difference between muscle training in addition with turning based specific training on balance in post stroke patients (p<0.05).

Null hypothesis:

1.1H0 -There will be statistically no significant difference of muscle training with turning based specific training on turning in Gait among post-stroke patients (p>0.05) 2 .2HO-There will be statistically no significant difference of muscle training with turning specific training on balance in post stroke patients (p>0.05)Research Design: Experimental study. Randomized Control Trial

Clinical setting: Rehabilitation department, Fauji Foundation Hospital.

Selection Criteria:

Inclusion Criteria

  • Age group: 45-60 years onwards
  • Both males and females
  • Patients with subacute and chronic stroke (MCA >6months)
  • MMSE- 25 or higher, Functional ambulatory capacity-3

Exclusion Criteria

  • Hemorrhagic stroke.
  • Patients with epilepsy
  • Patients with other neurological conditions loke Alzheimer, parkinsons and dementias.

Sampling technique: non-probability purposive sampling.

Outcome Measures:

TURNING: 1) Standing Turn Test, 2) Figure of 8 Test. BALANCE: 1) Berg Balance Scale, 2) Timed up and Go Test, 3) Modified 4 square step Test.

Outcome measures will be evaluated at baseline and then after 6 weeks of intervention.

Experimental Group (A) = This group will recieve Turning based specific training along with Functional muscle training for 6 weeks.

Control group (B) = This group will recieive Turning Based Specific Training only for 6 weeks

Data analysis techniques:

The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study.

Significance of the study:

Turning is a major component of ambulation. Difficulty in turning results in increased risk of fall. Stroke results in step asymmetry which increases difficulty in changing direction.

There is sufficient evidence available for normal gait training but limited protocols for targetting turning in Gait.

The current study aims to fill this gap by providing research data and developing a treatment protocol.

Study Type

Interventional

Enrollment (Estimated)

32

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 Contact

Study Locations

  • Pakistan
    • Punjab
      • Islamabad, Punjab, Pakistan, 44000
        • Recruiting
        • Foundation University College of Physical Therapy
        • Contact:

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:

  • Age group: 45-60 years onwards
  • Both males and females
  • Subacute and chronic stroke (MCA >6months)
  • MMSE score 25 or higher.
  • FAC -3

Exclusion Criteria:

  • Hemorrhagic stroke.
  • Patients with Epilepsy.
  • Patients with other neurological conditions like Alzheimer, Parkinson and other Dementias.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
It includes participants receiving Functional muscle training along with Turning based specific training over a period of 6 weeks.
Procedure: Turning based specific training along with functional Muscle training

Experimental group will receive Turning based specific training protocol for 6 weeks along with functional muscle training, training will be done on alternate days.

Functional muscle training:

Details: Week 1-6: 3 days a week on alternate days.

Hip Abductors:

Side lying leg raises Single leg squatting Standing leg wall press Progressing to Adding resistance bands

Hip adductors:

Side lying adduction Standing Adduction Progress to adding resistance bands

Hip Flexors:

Standing leg lift Straight leg raises Progress to adding resistance bands

Hip Extensors:

Prone lying raises Standing single leg extension Progress to adding resistance bands

Plantarflexors/ DorsiFlexors:

Plantarflexors:

Plantarflexion against resistance Toe raises

Dorsiflexors:

Dorsiflexion against resistance Heel raises

Hip external rotators:

Sitting-externally rotate hip 0-30° Add resistance bands

Hip Internal rotators:

Sitting-internally rotate the hip 0-30° Add resistance bands.
Active Comparator: Control Group
It includes participants recieving Turning based specific training only for 6 weeks.
Procedure: turning based specific training.

Week 1:

90 Degrees turns on the spot

Visual cues to follow

Week 2-3:

90 degrees turns on the spot

Figure of 8 walking

Visual cues to follow

Week 4-5:

90 Degrees turns on the spot

Figure of 8 walking

Step across body

Braiding

Week 6:

90 degree turns on the spot

Figure of 8 walking

Step across body

Braiding

Visual cues to follow

Obstacle avoidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Turning performance.
Time Frame: 6 weeks
Standing turn test will be used for turning performance
6 weeks
turning ability
Time Frame: 6 weeks
Figure of 8 test will be used for turning ability
6 weeks
Balance
Time Frame: 6 weeks
Berg Balance Scale will be used to assess balance
6 weeks
Balance
Time Frame: 6 weeks
Four square stand test will be used for this
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: 6 weeks
Timed up and go test will be used for this
6 weeks

Collaborators and Investigators

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

Sponsor

Foundation University Islamabad

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)

June 20, 2024

Primary Completion (Estimated)

December 20, 2024

Study Completion (Estimated)

January 20, 2025

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 19, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUI/CTR/2024/61

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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