NCT04479774

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

July 16, 2020

Last Update Submit

September 1, 2020

Conditions

Keywords

compelled body shift techniquestroketinetti performance oriented mobility assessment

Outcome Measures

Primary Outcomes (1)

  • 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. 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 Outcomes (2)

  • A 10meter walk test

    upto 6 weeks

  • Camry 160 Analog Weight Scale

    upto 6 weeks

Study Arms (2)

Experimental Group (Group A)

EXPERIMENTAL

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

Control group: (Group B)

OTHER

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

Interventions

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.

Experimental Group (Group A)

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.

Control group: (Group B)

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Usman Farooq, Mspt

Peshawar, Khyber Pakhtunkhwa, 25000, 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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants random allocation into control and experimental groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Usman Farooq PT

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 21, 2020

Study Start

July 12, 2020

Primary Completion

August 29, 2020

Study Completion

August 31, 2020

Last Updated

September 2, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations