Chronic StrokeNCT04479774
Effects of Compelled Body Weight Shift Technique for Rehabilitation of Individuals With Chronic Stroke
A study testing Compelled Body Weight Shift Technique and Compelled Body Weight Shift Technique without insole in people with Chronic Stroke, run by Northwest Institute of Health Sciences, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Compelled Body Weight Shift Technique and Compelled Body Weight Shift Technique without insole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Jul 2020to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Stroke
- Being tested
- Compelled Body Weight Shift Technique, Compelled Body Weight Shift Technique without insole
- Keywords
- compelled body shift technique, stroke, tinetti performance oriented mobility assessment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compelled Body Weight Shift TechniqueOther
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.
Compelled Body Weight Shift Technique without insoleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Compelled Body Weight Shift Technique without insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: upto 6 weeks
Secondary outcomes (2)
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
Measured: upto 6 weeks
Camry 160 Analog Weight Scale
Camry 160 Analog Weight Scale to check the weight in kilograms
Measured: upto 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start12 Jul 2020
- Primary completion29 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants random allocation into control and experimental groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwest Institute of Health Sciences, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Usman Farooq, Northwest Institute of Health Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479774
- Sponsor's protocol ID
- NWIHS-0001/IRB/01
- Status last verified
- Sep 2020
- First submitted
- 16 Jul 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Compelled Body Weight Shift Technique for Rehabilitation of Individuals With Chronic Stroke
- ClinicalTrials.gov ID
- NCT04479774
- Acronym / sponsor ID
- NWIHS-0001/IRB/01
- Conditions
- Chronic Stroke
- Keywords
- compelled body shift technique, stroke, tinetti performance oriented mobility assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Northwest Institute of Health Sciences, PakistanUniversity, hospital or other
- Study start
- 12 Jul 2020 (actual)
- Primary completion
- 29 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants random allocation into control and experimental groups
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (Group A) | Experimental | Other: Compelled Body Weight Shift TechniqueSubjects 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. |
| Control group: (Group B) | Other | Other: Compelled Body Weight Shift Technique without insoleSubjects 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- • Serious or unstable medical, condition of patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compelled Body Weight Shift TechniqueRoutine 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 | Experimental Group (Group A) |
| Compelled Body Weight Shift Technique without insoleRoutine 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. | Other | Control group: (Group B) |
Primary outcome
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]
2 secondary outcomes
A 10meter walk test
Time frame: upto 6 weeks
Camry 160 Analog Weight Scale
Time frame: upto 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: Yes
Related trials for Chronic Stroke
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Recruiting
Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
Stroke, Ischemic, Chronic Stroke
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Not yet recruiting
Proof-of-concept for Use of Transcutaneous Spinal Stimulation (TSS) With the ExaStim® Stimulation System in Adults With Chronic Ischemic Stroke
Chronic Stroke, Ischemic Stroke
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compelled Body Weight Shift Technique and Compelled Body Weight Shift Technique without insole in people with Chronic Stroke, run by Northwest Institute of Health Sciences, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinetti Performance Oriented Mobility Assessment (time frame: upto 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.