Effects of Compelled Body Weight Shift Technique for Rehabilitation of Individuals With Chronic Stroke

September 1, 2020 updated by: Usman Farooq, Northwest Institute of Health Sciences, Pakistan
Stroke is one of the major cause of lifelong disability if not treated on time, the investigator's technique knows as Compelled Body Weight Shift Technique (CBWS) was utilized and administered to chronic stroke population and results were figured out using gait parameters and Tinetti POMA scale.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Total 28 sample size out of which 27 were divided into control and experimental group. Inclusion criteria was Unilateral chronic stroke with asymmetrical stance, Patients with score of 3,4 and 5 will be included according to FAS (Functional Ambulation Scale), Ability to understand and follow instructions, Both male and female, Any type of stroke, and Age 40-60. Written and informed consent was obtained from participants of study. Six weeks of exercise training was combined with compelled body weight shift technique via shoe lift of 0.6 cm thickness for experimental group and for control group training was performed without shoe lift.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Pakistan
    • KP
      • Peshawar, KP, Pakistan, 25000
        • Usman Farooq, Mspt

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unilateral chronic stroke with asymmetrical stance
  • Patients with score of 3,4 and 5 were included according to functional ambulation scale(59)
  • Ability to understand and follow instruction
  • Both male and female.
  • Any type of stroke.
  • Age 40-60.

Exclusion Criteria:

  • • Serious or unstable medical, condition of patient.

    • History of other neurological diseases (i.e. Parkinson's disease, multiple sclerosis),
    • Contractures or any deformity.
    • Leg Length Discrepancy

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group (Group A)

Subjects were randomly assigned and informed consent was obtained, the subjects were educated about treatment and on the basis of functional ambulation scale 3,4 and 5 subjects were included, along with this the subjects of age group between 40-60 having ability to understand and follow instructions were included in study.

Results were obtained by using gait parameters including walk speed, cadence, step rate, stride length The tinetti POMA scale was utilized to record changes post treatment in gait , the weight bearing was recorded using Camry ZT-160 analog weight scale At the end of every week results were obtained.
Other: Compelled Body Weight Shift Technique

Routine Physical Therapy with 0.6 cm thickness insole inserted in shoe of unaffected side and following exercises were performed by patients

  • Muscle re-education
  • Sit to stand exercise , 4 to 10 repetitions
  • Supported heel raise to 10 repetitions with 3 sets
  • Supported squat exercise tibialis anterior and quads muscles to 10 repetitions with 3 sets
  • Gait training
  • Forward walk in parallel bars with number of 10 rounds.
  • Task oriented training balance training
  • A. Stepping exercise on 15 cm height step and number of repetitions 10.
  • B. Tandem standing for 10 seconds.
  • C. Reaching exercise in which patient performed reaching for object in therapists hand and the number of repetitions was 10.
Other: Control group: (Group B)

Subjects were randomly assigned and informed consent was obtained, the subjects were educated about treatment and on the basis of functional ambulation scale 3,4 and 5 subjects were included, along with this the subjects of age group between 40-60 having ability to understand and follow instructions were included in study.

Results were obtained by using gait parameters including walk speed, cadence, step rate, stride length The tinetti POMA scale was utilized to record changes post treatment in gait , the weight bearing was recorded using Camry ZT-160 analog weight scale At the end of every week results were obtained.
Other: Compelled Body Weight Shift Technique without insole

Routine Physical Therapy without 0.6 cm thickness insole inserted in shoe of unaffected side and following exercises were performed by patients

  • Muscle re-education
  • Sit to stand exercise , 4 to 10 repetitions
  • Supported heel raise to 10 repetitions with 3 sets
  • Supported squat exercise tibialis anterior and quads muscles to 10 repetitions with 3 sets
  • Gait training
  • Forward walk in parallel bars with number of 10 rounds.
  • Task oriented training balance training
  • A. Stepping exercise on 15 cm height step and number of repetitions 10.
  • B. Tandem standing for 10 seconds.
  • C. Reaching exercise in which patient performed reaching for object in therapists hand and the number of repetitions was 10.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tinetti Performance Oriented Mobility Assessment
Time Frame: upto 6 weeks

Tinetti Performance Oriented Mobility Assessment The Tinetti, evaluation instrument is, an effectively managed, task-arranged test that, quantifies gait and balance activities of patients. A three-point, ordinal scale, extending from 0-2. "0" demonstrates the most elevated level of debilitation and "2" the people's freedom.

  1. Total Balance Score = 16
  2. Total Gait Score = 12
  3. Maximum total test Score = 28 [Time Frame: upto 6 weeks]
upto 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
A 10meter walk test
Time Frame: upto 6 weeks
A 10meter walk test A ten meter distance employed, to determine functional mobility and gait speed, the ten meter walk test was performed by patient at self-selected walking pace and fast walking pace
upto 6 weeks
Camry 160 Analog Weight Scale
Time Frame: upto 6 weeks
Camry 160 Analog Weight Scale to check the weight in kilograms
upto 6 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwest Institute of Health Sciences, Pakistan

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NWIHS-0001/IRB/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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