StrokeperturbationNCT03234426
Effectiveness of Perturbations Exercises in Improving Balance, Function and Mobility in Stroke Patients
A study testing Perturbation and Conventional Physiotherapy Treatment in people with Stroke, run by Mahatma Gandhi Institute of Medical Sciences at 1 site in India.
Trial summary
Following stroke, patients loses functions of the motor, sensory and higher brain cognitive faculties to various degrees which lead to diminished balance. It has been documented that hemiplegic or hemiparetic stroke patients presented with more posture sway, asymmetric weight distribution, impaired weight-shifting… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Perturbation and Conventional Physiotherapy Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2014to Dec 2014
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First ever stroke
- Age ranges between 40-70
- Both genders were included
- Ambulatory patients with or without ambulatory aids
- Occurrence of stroke at within 0-3 months i.e.-sub acute
- Able to follow command
- Mini mental scale examinations not less than 24
Who cannot join
- Patients who has severe limitations in passive range of motion at lower extremities
- Patients with impaired sensory, proprioceptor, cognitive and perceptual ability
- Patient who has contracture
- Orthopedic or any other neurological disorder which impair balance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Perturbations Exercises in Improving Balance, Function and Mobility in Stroke Patients.
Following stroke, patients loses functions of the motor, sensory and higher brain cognitive faculties to various degrees which lead to diminished balance. It has been documented that hemiplegic or hemiparetic stroke patients presented with more posture sway, asymmetric weight distribution, impaired weight-shifting ability and decreased stability capability. There are many balance exercises and strategies; to improve balance in elderly age group population, to prevent fall prevention. But we have very few evidences of giving manual perturbation balance training in stroke patients to improve speed, balance and function. Therefore this study is taken up to examine whether the manual perturbation balance training is more effective in improving speed, balance and function in stroke patients.
Read the detailed description
There are many more studies done for elderly populations, normal individuals for improving balance by giving perturbation based balance training.All perturbation exercises are given by either mechanical or by self reaching tasks in forward,backward,and in both sideways. There are very studies ;who attempted perturbation based balance training to improve balance in elderly population but not for stroke patients for their Speed, Balance and Function.The manual perturbation exercise can be an promising intervention in the future for various conditions
- Conditions
- Stroke
- Being tested
- Perturbation, Conventional Physiotherapy Treatment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerturbationOther
Also called Manual Perturbation
Manual perturbations were given at waist region,over the Shoulders. in following positions- sitting, kneeling, standing positions,10 perturbations were given in forward,backward,both right and left side, 6 days in a week all precautionary measures taken for the patient's safety
Conventional Physiotherapy TreatmentOther
Also called control Group
Conventional Physiotherapy treatment were given to participants included in this group for 30 mins daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | manual perturbations were given in forward, Backward,right and left sideways, 10 perturbations were given,6 days in week,in fallowing positions- sitting,kneeling, standing positions Receives: Other: Perturbation; Other: Conventional Physiotherapy Treatment |
| Control group | Placebo comparator | Conventional Physiotherapy were given 6 days in a week, for 30 mins for 4 weeks, includes stretching, strengthening of contralateral limbs Receives: Other: Perturbation; Other: Conventional Physiotherapy Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
patients ability of balance were assessed
Measured: 4 weeks
Secondary outcomes (1)
Functional Independence Scale
ability of Functional independent level for Activity Of Daily Living were assessed
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahatma Gandhi Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nawaj Pathan, Mahatma Gandhi Institute of Medical Sciences
- Investigators
- Nawaj Pathan, PG student, Principal investigator, MGM School Of Physiotherapy,Aurangabad,Maharashtra, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234426
- Sponsor's protocol ID
- MGM ECRHS 2014/160
- Acronym
- perturbation
- Status last verified
- Jul 2017
- First submitted
- 10 Dec 2014
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Perturbations Exercises in Improving Balance, Function and Mobility in Stroke Patients.
- ClinicalTrials.gov ID
- NCT03234426
- Acronym / sponsor ID
- perturbation / MGM ECRHS 2014/160
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mahatma Gandhi Institute of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 31 Jul 2017 (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.
Following stroke, patients loses functions of the motor, sensory and higher brain cognitive faculties to various degrees which lead to diminished balance. It has been documented that hemiplegic or hemiparetic stroke patients presented with more posture sway, asymmetric weight distribution, impaired weight-shifting ability and decreased stability capability. There are many balance exercises and strategies; to improve balance in elderly age group population, to prevent fall prevention. But we have very few evidences of giving manual perturbation balance training in stroke patients to improve speed, balance and function. Therefore this study is taken up to examine whether the manual perturbation balance training is more effective in improving speed, balance and function in stroke patients.
Detailed description
There are many more studies done for elderly populations, normal individuals for improving balance by giving perturbation based balance training.All perturbation exercises are given by either mechanical or by self reaching tasks in forward,backward,and in both sideways. There are very studies ;who attempted perturbation based balance training to improve balance in elderly population but not for stroke patients for their Speed, Balance and Function.The manual perturbation exercise can be an promising intervention in the future for various conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Perturbation, Other: Conventional Physiotherapy Treatmentmanual perturbations were given in forward, Backward,right and left sideways, 10 perturbations were given,6 days in week,in fallowing positions- sitting,kneeling, standing positions |
| Control group | Placebo comparator | Other: Perturbation, Other: Conventional Physiotherapy TreatmentConventional Physiotherapy were given 6 days in a week, for 30 mins for 4 weeks, includes stretching, strengthening of contralateral limbs |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- First ever stroke
- Age ranges between 40-70
- Both genders were included
- Ambulatory patients with or without ambulatory aids
- Occurrence of stroke at within 0-3 months i.e.-sub acute
Key exclusion criteria (4 listed)
- Patients who has severe limitations in passive range of motion at lower extremities
- Patients with impaired sensory, proprioceptor, cognitive and perceptual ability
- Patient who has contracture
- Orthopedic or any other neurological disorder which impair balance
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 |
|---|---|---|
| PerturbationAlso: Manual PerturbationManual perturbations were given at waist region,over the Shoulders. in following positions- sitting, kneeling, standing positions,10 perturbations were given in forward,backward,both right and left side, 6 days in a week all precautionary measures taken for the patient's safety | Other | Control group, Experimental Group |
| Conventional Physiotherapy TreatmentAlso: control GroupConventional Physiotherapy treatment were given to participants included in this group for 30 mins daily for 4 weeks | Other | Control group, Experimental Group |
Primary outcome
Berg Balance Scale
Time frame: 4 weeks
patients ability of balance were assessed
1 secondary outcome
Functional Independence Scale
Time frame: 4 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 31 Jul 2017.
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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.
Nawaj Pathan, PG student principal investigator
MGM School Of Physiotherapy,Aurangabad,Maharashtra, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perturbation and Conventional Physiotherapy Treatment in people with Stroke, run by Mahatma Gandhi Institute of Medical Sciences at 1 site in India.
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 7 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 31 Jul 2017. 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 India. 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. Some participants in this study may receive a placebo. 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?
Berg Balance Scale (time frame: 4 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 31 Jul 2017.