Stroke PatientNCT04468269
Task-oriented Balance Training With Sensory Integration
A study testing Task oriented balance training with sensory integration group and Task oriented balance training without sensory integration group in people with Stroke Patient, run by Riphah International University at 1 site in Pakistan.
Trial summary
Objectives of this study are to determine the effect of task-oriented balance training on balance, postural stability and mobility in Stroke patients, to determine the effect of task-oriented balance training with sensory integration on balance, postural stability and mobility in post Stroke patients and to compare… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stroke Patient
- What is being tested?
- Task oriented balance training with sensory integration group and Task oriented balance training without sensory integration group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2019to 15 Jan 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- At least 6 months post stroke,
- Stability of neurological severity
- An ability to understand and perform the test
- Ability to maintain standing position without aids for at least 5 minutes
- GRADE II, III, IV on Functional mobility Scale.
Who cannot join
- Posterior circulation stroke
- Deficits of somatic sensation involving the paretic lower limb
- Presence of severe Hemiplegia
- Vestibular disorders, paroxysmal vertigo
- Presence of other neurological conditions such as neglect, hemianopsia and pushing syndrome
- Presence of orthopedic diseases involving the lower limbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Task-oriented Balance Training With Sensory Integration in Post-stroke Patients.
Objectives of this study are to determine the effect of task-oriented balance training on balance, postural stability and mobility in Stroke patients, to determine the effect of task-oriented balance training with sensory integration on balance, postural stability and mobility in post Stroke patients and to compare the effect of balance training with and without sensory integration on balance, postural stability and mobility in stroke patients. Study Design is Randomized control trial. Sample Size is 60 calculated through open Epi tool. Sampling Technique is Non-probability purposive sampling technique then randomization through sealed envelope method into control and experimental group. Duration of study is 6 months. Study Setting Rafsan Stroke Center Peshawar.
Read the detailed description
Stroke is the leading cause of high levels of morbidity and long-term functional disability in adults. Stroke is a clinical syndrome characterized by rapidly developing symptoms and/or signs of focal and at times global (for patients in Coma) loss of cerebral functions, with symptoms lasting more than 24 hours or leading to death with no apparent cause other than that of vascular origin. The incident of stroke is rising steadily, According to estimates by the WHO, stroke accounted for 5.7 million deaths and 16 million first-time events in 2005 and these numbers may reach 7.8 million and 23 million by 2030, respectively. Stroke is the second leading cause of preventable death worldwide and the fourth leading cause of lost productivity, as measured by disability-adjusted life years. World Health Organization reported that total mortality due to stroke in Pakistan was 78512.2 WHO estimate for the year 2020 predict that stroke will remain the second leading cause of death after ischemic heart disease, both in developing and developed countries. Annually, fifteen millions people worldwide suffer a stroke. Of these, five million dies and another five million are left permanently disabled, placing a burden on family and community. When balance impairment is affected early after stroke, performance of simple and complex tasks become difficult which results in their functional mobility. Impaired balance has also been identified as the strongest predictor of falling, which in turn is related to fear of falling, limited activity and quality of life. Thus, this vicious cycle of balance disability is continued, resulting in delaying the recovery process of stroke rehabilitation. Sensory impairment reduces sensory processing ability, thereby reducing motor and balance responses. Muscle weakness causes a muscular imbalance between the paretic and non-paretic sides, resulting in weight-bearing imbalance and an asymmetric posture during standing. As a result, functional activities such as sit-to-stand, standing, walking, and balance control are limited. Different interventions were used for the restoration of functional activities mobility and balance in post-stroke patients. A task-oriented approach is one method used to overcome limited functional activities. Previous studies have reported that the application of this approach was effective in improving functional activities in stroke patients. Shumway-Cook and Woollacott reported that movements are generated by the interaction of various systems in the brain, organized with a focus on goals, and limited by the environment. Because the task-oriented approach focuses on goals and the environment, it may be a suitable method for overcoming limited functional activities. The effective integration of visual, somatosensory, and vestibular information is necessary to maintain balance ability during functional activities. Stroke patients rely highly on visual information due to a lack of somatic and vestibular senses. Therefore, it is necessary to restore sensory integration in stroke patients through the manipulation of somatic, visual and vestibular senses. Task-oriented balance training is proved to be effective for improvement of balance in stroke patients. Sensory balance training has also shown a beneficial effect on balance and mobility of stroke patients. There is limited evidence on the effects gained by task-oriented balance training with altered sensory input This study aims to determine the effects gained by combining the task-oriented balance training with sensory integration.
- Conditions
- Stroke Patient
- Being tested
- Task oriented balance training with sensory integration group, Task oriented balance training without sensory integration group
- Keywords
- task oriented balance training, sensory integration, stroke patients.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task oriented balance training with sensory integration groupOther
Sitting position:
- Sit in a chair without backrest while keeping the feet on floor.
- Sit on a ball while keeping the feet on the floor.
Sit to stand:
- Sit in a chair without a backrest
- Sit in a chair without a backrest with and perform the sit-to-stand motion repeatedly.
- Sit on a ball and perform the sit-to-stand motion repeatedly.
Standing position:
Perform bipedal standing Control Of Weight Shifting. Perform a semi-tandem stance. One Foot Standing.
Walking:
- Walk forward
- Walk forward cross an obstacle, and then continue to walk.
- Walk Lateral
- Walk Backward
- Tandem walk
Task oriented balance training without sensory integration groupOther
Sitting position:
- Sit in a chair without a backrest while keeping the feet on a firm surface.
- Sit on a ball while keeping the feet on the firm surface
Sit to stand:
- Sit in a chair without a backrest with the feet on a firm surface and perform the sit-to-stand motion repeatedly.
- Sit on a ball with the feet on the firm surface and perform the sit-to-stand motion repeatedly.
Standing position:
- Perform bipedal standing on a firm surface.
- Perform a semi-tandem stance on the firm surface
Walking:
- Walk forward on a firm surface.
- Walk forward on the firm surface, cross an obstacle, and then continue to walk.
- Walk sideways
- Walk Backward
- Tandem walk
| Study group | Role | What they receive |
|---|---|---|
| balance training with sensory integration group | Experimental | Conventional treatment: Static stretching exercises such as trunk rotation, flexion, and extension; hip flexors stretch, standing hamstring stretch; plantar flexors stretch, shoulder, elbow and wrist flexors and supinators stretch. Stretching will be applied for 30-sec hold with 30-sec rest. 3-5 times for each muscle group. For 40 min/day and 3 days/week for 6 weeks to improve balance and postural stability. Receives: Other: Task oriented balance training with sensory integration group |
| balance training without sensory integration group | Experimental | Conventional treatment: Static stretching exercises such as trunk rotation, flexion, and extension; hip flexors stretch, standing hamstring stretch; plantar flexors stretch, shoulder, elbow and wrist flexors and supinators stretch. Stretching will be applied for 30-sec hold with 30-sec rest. 3-5 times for each muscle group.For 40 min/day and 3 days/week for 6 weeks to improve balance and postural stability Receives: Other: Task oriented balance training without sensory integration group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg balance scale (BBS)
The Berg balance scale (BBS) is used to assess the participant's ability to retain stability The BBS is a widely used test for the assessment of elderly population with impairment of balance and individuals with neurological disorder while sitting, standing, and transferring. This test included both static and dynamic type task. The BBS uses a five-point ordinal scale ranging from 0 (disability) to 4(complete independent performance) and consists of 14 components; the maximum score is 56 points.A score of 56 indicates functional balance.A score of < 45 indicates individuals may be at greater risk of falling
Measured: From baseline to 6th week
Balance error scoring system (BESS)
It is objective method of assessing static postural stability. Subjects are asked to perform Double leg stance, Single leg stance, Tandem Stance on firm surface and then on foam surface. The numbers of errors during performance of these tasks are assessed.
Measured: From baseline to 6th week
The Activities-specific Balance Confidence (ABC)
Activities-specific balance confidence (ABC) scale is 16 items scale it is a subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. Items are rated on a rating scale that ranges from 0-100. The overall score was calculated by adding item scores and then divided by a total number of items.
Measured: From baseline to 6th week
Dynamic Gait Index
It is an 8-item test. Developed to assess the likelihood of falling in older adults A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function. Total Score of this test is 24.Score< 19/24 = is a predictive risk of falls.
Measured: From baseline to 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start15 Jun 2019
- Primary completion15 Dec 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Stroke PatientStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468269
- Sponsor's protocol ID
- REC/00558 Sohail Iqbal
- Status last verified
- Jul 2020
- First submitted
- 8 Jul 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walker C, Brouwer BJ, Culham EG. Use of visual feedback in retraining balance following acute stroke. Phys Ther. 2000 Sep;80(9):886-95.
PubMed 10960936Park MH, Won JI. The effects of task-oriented training with altered sensory input on balance in patients with chronic stroke. J Phys Ther Sci. 2017 Jul;29(7):1208-1211. doi: 10.1589/jpts.29.1208. Epub 2017 Jul 15.
PubMed 28744049Lamb SE, Ferrucci L, Volapto S, Fried LP, Guralnik JM; Women's Health and Aging Study. Risk factors for falling in home-dwelling older women with stroke: the Women's Health and Aging Study. Stroke. 2003 Feb;34(2):494-501.
PubMed 12574566Kuklina EV, Tong X, George MG, Bansil P. Epidemiology and prevention of stroke: a worldwide perspective. Expert Rev Neurother. 2012 Feb;12(2):199-208. doi: 10.1586/ern.11.99.
PubMed 22288675Bayouk JF, Boucher JP, Leroux A. Balance training following stroke: effects of task-oriented exercises with and without altered sensory input. Int J Rehabil Res. 2006 Mar;29(1):51-9. doi: 10.1097/01.mrr.0000192100.67425.84.
PubMed 16432390Dean CM, Shepherd RB. Task-related training improves performance of seated reaching tasks after stroke. A randomized controlled trial. Stroke. 1997 Apr;28(4):722-8. doi: 10.1161/01.str.28.4.722.
PubMed 9099186Bonan IV, Colle FM, Guichard JP, Vicaut E, Eisenfisz M, Tran Ba Huy P, Yelnik AP. Reliance on visual information after stroke. Part I: Balance on dynamic posturography. Arch Phys Med Rehabil. 2004 Feb;85(2):268-73. doi: 10.1016/j.apmr.2003.06.017.
PubMed 14966712
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Task-oriented Balance Training With Sensory Integration in Post-stroke Patients.
- ClinicalTrials.gov ID
- NCT04468269
- Acronym / sponsor ID
- REC/00558 Sohail Iqbal
- Conditions
- Stroke Patient
- Keywords
- task oriented balance training, sensory integration, stroke patients.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 13 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.
Objectives of this study are to determine the effect of task-oriented balance training on balance, postural stability and mobility in Stroke patients, to determine the effect of task-oriented balance training with sensory integration on balance, postural stability and mobility in post Stroke patients and to compare the effect of balance training with and without sensory integration on balance, postural stability and mobility in stroke patients. Study Design is Randomized control trial. Sample Size is 60 calculated through open Epi tool. Sampling Technique is Non-probability purposive sampling technique then randomization through sealed envelope method into control and experimental group. Duration of study is 6 months. Study Setting Rafsan Stroke Center Peshawar.
Detailed description
Stroke is the leading cause of high levels of morbidity and long-term functional disability in adults. Stroke is a clinical syndrome characterized by rapidly developing symptoms and/or signs of focal and at times global (for patients in Coma) loss of cerebral functions, with symptoms lasting more than 24 hours or leading to death with no apparent cause other than that of vascular origin. The incident of stroke is rising steadily, According to estimates by the WHO, stroke accounted for 5.7 million deaths and 16 million first-time events in 2005 and these numbers may reach 7.8 million and 23 million by 2030, respectively. Stroke is the second leading cause of preventable death worldwide and the fourth leading cause of lost productivity, as measured by disability-adjusted life years. World Health Organization reported that total mortality due to stroke in Pakistan was 78512.2 WHO estimate for the year 2020 predict that stroke will remain the second leading cause of death after ischemic heart disease, both in developing and developed countries. Annually, fifteen millions people worldwide suffer a stroke. Of these, five million dies and another five million are left permanently disabled, placing a burden on family and community. When balance impairment is affected early after stroke, performance of simple and complex tasks become difficult which results in their functional mobility. Impaired balance has also been identified as the strongest predictor of falling, which in turn is related to fear of falling, limited activity and quality of life. Thus, this vicious cycle of balance disability is continued, resulting in delaying the recovery process of stroke rehabilitation. Sensory impairment reduces sensory processing ability, thereby reducing motor and balance responses. Muscle weakness causes a muscular imbalance between the paretic and non-paretic sides, resulting in weight-bearing imbalance and an asymmetric posture during standing. As a result, functional activities such as sit-to-stand, standing, walking, and balance control are limited. Different interventions were used for the restoration of functional activities mobility and balance in post-stroke patients. A task-oriented approach is one method used to overcome limited functional activities. Previous studies have reported that the application of this approach was effective in improving functional activities in stroke patients. Shumway-Cook and Woollacott reported that movements are generated by the interaction of various systems in the brain, organized with a focus on goals, and limited by the environment. Because the task-oriented approach focuses on goals and the environment, it may be a suitable method for overcoming limited functional activities. The effective integration of visual, somatosensory, and vestibular information is necessary to maintain balance ability during functional activities. Stroke patients rely highly on visual information due to a lack of somatic and vestibular senses. Therefore, it is necessary to restore sensory integration in stroke patients through the manipulation of somatic, visual and vestibular senses. Task-oriented balance training is proved to be effective for improvement of balance in stroke patients. Sensory balance training has also shown a beneficial effect on balance and mobility of stroke patients. There is limited evidence on the effects gained by task-oriented balance training with altered sensory input This study aims to determine the effects gained by combining the task-oriented balance training with sensory integration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| balance training with sensory integration group | Experimental | Other: Task oriented balance training with sensory integration groupConventional treatment: Static stretching exercises such as trunk rotation, flexion, and extension; hip flexors stretch, standing hamstring stretch; plantar flexors stretch, shoulder, elbow and wrist flexors and supinators stretch. Stretching will be applied for 30-sec hold with 30-sec rest. 3-5 times for each muscle group. For 40 min/day and 3 days/week for 6 weeks to improve balance and postural stability. |
| balance training without sensory integration group | Experimental | Other: Task oriented balance training without sensory integration groupConventional treatment: Static stretching exercises such as trunk rotation, flexion, and extension; hip flexors stretch, standing hamstring stretch; plantar flexors stretch, shoulder, elbow and wrist flexors and supinators stretch. Stretching will be applied for 30-sec hold with 30-sec rest. 3-5 times for each muscle group.For 40 min/day and 3 days/week for 6 weeks to improve balance and postural stability |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- At least 6 months post stroke,
- Stability of neurological severity
- An ability to understand and perform the test
- Ability to maintain standing position without aids for at least 5 minutes
- GRADE II, III, IV on Functional mobility Scale.
Key exclusion criteria (6 listed)
- Posterior circulation stroke
- Deficits of somatic sensation involving the paretic lower limb
- Presence of severe Hemiplegia
- Vestibular disorders, paroxysmal vertigo
- Presence of other neurological conditions such as neglect, hemianopsia and pushing syndrome
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 |
|---|---|---|
| Task oriented balance training with sensory integration groupSitting position: 1. Sit in a chair without backrest while keeping the feet on floor. 2. Sit on a ball while keeping the feet on the floor. Sit to stand: 1. Sit in a chair without a backrest 2. Sit in a chair without a backrest with and perform the sit-to-stand motion repeatedly. 3. Sit on a ball and perform the sit-to-stand motion repeatedly. Standing position: Perform bipedal standing Control Of Weight Shifting. Perform a semi-tandem stance. One Foot Standing. Walking: 1. Walk forward 2. Walk forward cross an obstacle, and then continue to walk. 3. Walk Lateral 4. Walk Backward 5. Tandem walk | Other | balance training with sensory integration group |
| Task oriented balance training without sensory integration groupSitting position: 1. Sit in a chair without a backrest while keeping the feet on a firm surface. 2. Sit on a ball while keeping the feet on the firm surface Sit to stand: 1. Sit in a chair without a backrest with the feet on a firm surface and perform the sit-to-stand motion repeatedly. 2. Sit on a ball with the feet on the firm surface and perform the sit-to-stand motion repeatedly. Standing position: 1. Perform bipedal standing on a firm surface. 2. Perform a semi-tandem stance on the firm surface Walking: 1. Walk forward on a firm surface. 2. Walk forward on the firm surface, cross an obstacle, and then continue to walk. 3. Walk sideways 4. Walk Backward 5. Tandem walk | Other | balance training without sensory integration group |
Primary outcome
Berg balance scale (BBS)
Time frame: From baseline to 6th week
The Berg balance scale (BBS) is used to assess the participant's ability to retain stability The BBS is a widely used test for the assessment of elderly population with impairment of balance and individuals with neurological disorder while sitting, standing, and transferring. This test included both static and dynamic type task. The BBS uses a five-point ordinal scale ranging from 0 (disability) to 4(complete independent performance) and consists of 14 components; the maximum score is 56 points.A score of 56 indicates functional balance.A score of < 45 indicates individuals may be at greater risk of falling
Balance error scoring system (BESS)
Time frame: From baseline to 6th week
It is objective method of assessing static postural stability. Subjects are asked to perform Double leg stance, Single leg stance, Tandem Stance on firm surface and then on foam surface. The numbers of errors during performance of these tasks are assessed.
The Activities-specific Balance Confidence (ABC)
Time frame: From baseline to 6th week
Activities-specific balance confidence (ABC) scale is 16 items scale it is a subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. Items are rated on a rating scale that ranges from 0-100. The overall score was calculated by adding item scores and then divided by a total number of items.
Dynamic Gait Index
Time frame: From baseline to 6th week
It is an 8-item test. Developed to assess the likelihood of falling in older adults A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function. Total Score of this test is 24.Score< 19/24 = is a predictive risk of falls.
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 13 Jul 2020.
- Background: PubMed 10960936Walker C, Brouwer BJ, Culham EG. Use of visual feedback in retraining balance following acute stroke. Phys Ther. 2000 Sep;80(9):886-95.
- Background: PubMed 28744049Park MH, Won JI. The effects of task-oriented training with altered sensory input on balance in patients with chronic stroke. J Phys Ther Sci. 2017 Jul;29(7):1208-1211. doi: 10.1589/jpts.29.1208. Epub 2017 Jul 15.
- Background: PubMed 12574566Lamb SE, Ferrucci L, Volapto S, Fried LP, Guralnik JM; Women's Health and Aging Study. Risk factors for falling in home-dwelling older women with stroke: the Women's Health and Aging Study. Stroke. 2003 Feb;34(2):494-501.
- Background: PubMed 22288675Kuklina EV, Tong X, George MG, Bansil P. Epidemiology and prevention of stroke: a worldwide perspective. Expert Rev Neurother. 2012 Feb;12(2):199-208. doi: 10.1586/ern.11.99.
- Background: PubMed 16432390Bayouk JF, Boucher JP, Leroux A. Balance training following stroke: effects of task-oriented exercises with and without altered sensory input. Int J Rehabil Res. 2006 Mar;29(1):51-9. doi: 10.1097/01.mrr.0000192100.67425.84.
- Background: PubMed 9099186Dean CM, Shepherd RB. Task-related training improves performance of seated reaching tasks after stroke. A randomized controlled trial. Stroke. 1997 Apr;28(4):722-8. doi: 10.1161/01.str.28.4.722.
- Background: PubMed 14966712Bonan IV, Colle FM, Guichard JP, Vicaut E, Eisenfisz M, Tran Ba Huy P, Yelnik AP. Reliance on visual information after stroke. Part I: Balance on dynamic posturography. Arch Phys Med Rehabil. 2004 Feb;85(2):268-73. doi: 10.1016/j.apmr.2003.06.017.
- Individual participant dataSharing planned: No
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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.
Aruba Saeed, PHD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task oriented balance training with sensory integration group and Task oriented balance training without sensory integration group in people with Stroke Patient, run by Riphah International University 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 5 inclusion and 6 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 13 Jul 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?
Berg balance scale (BBS) (time frame: From baseline to 6th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04468269, which also lists 7 linked publications.
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 13 Jul 2020.