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

Primary Purpose

Chronic Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Compelled Body Weight Shift Technique
Compelled Body Weight Shift Technique without insole
Sponsored by
Northwest Institute of Health Sciences, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring compelled body shift technique, stroke, tinetti performance oriented mobility assessment

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Usman Farooq, Mspt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental Group (Group A)

Control group: (Group B)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Tinetti Performance Oriented Mobility Assessment
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. Total Balance Score = 16 Total Gait Score = 12 Maximum total test Score = 28 [Time Frame: upto 6 weeks]

Secondary Outcome Measures

A 10meter walk test
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
Camry 160 Analog Weight Scale
Camry 160 Analog Weight Scale to check the weight in kilograms

Full Information

First Posted
July 16, 2020
Last Updated
September 1, 2020
Sponsor
Northwest Institute of Health Sciences, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT04479774
Brief Title
Effects of Compelled Body Weight Shift Technique for Rehabilitation of Individuals With Chronic Stroke
Official Title
Effects of Compelled Body Weight Shift Technique for Rehabilitation of Individuals With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 12, 2020 (Actual)
Primary Completion Date
August 29, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwest Institute of Health Sciences, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
Keywords
compelled body shift technique, stroke, tinetti performance oriented mobility assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants random allocation into control and experimental groups
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group (Group A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group: (Group B)
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Compelled Body Weight Shift Technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Compelled Body Weight Shift Technique without insole
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tinetti Performance Oriented Mobility Assessment
Description
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. Total Balance Score = 16 Total Gait Score = 12 Maximum total test Score = 28 [Time Frame: upto 6 weeks]
Time Frame
upto 6 weeks
Secondary Outcome Measure Information:
Title
A 10meter walk test
Description
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
Time Frame
upto 6 weeks
Title
Camry 160 Analog Weight Scale
Description
Camry 160 Analog Weight Scale to check the weight in kilograms
Time Frame
upto 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Usman Farooq, Mspt
City
Peshawar
State/Province
KP
ZIP/Postal Code
25000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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