Stroke, IschemicNCT04557839
Balance Training on Vestibular Function and Proprioception Feedback in Stroke Patient
A study testing Traditional physical therapy balance exercise and proprioception based balance training in people with Stroke, Ischemic, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study was to find out the role of balance training on vestibular function and proprioception feedback in stroke patients. It was a randomized control trial and was conducted in civil hospital Gujranwala. Current study was completed within the time duration of 6 month. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Traditional physical therapy balance exercise and proprioception based balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Feb 2020to 15 Sep 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with impaired balance ,vestibular function and proprioception due to stroke
- Victim of a stroke that resulted in hemiparesis,
- Be at least 6 months
- Be fully discharged from all rehabilitation program
Who cannot join
- Those with recurrent strokes
- Bilateral hemispheric cerebellar or brain stem lesions
- Severe spasticity or cognitive deficit
- Orthopedic or peripheral neuropathy
- Significant visual field or hemi neglect problems were excluded.
- They were medically unstable as determined by examination, history, or medical records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Balance Training on Vestibular Function and Proprioception Feedback in Stroke Patient
The aim of this study was to find out the role of balance training on vestibular function and proprioception feedback in stroke patients. It was a randomized control trial and was conducted in civil hospital Gujranwala. Current study was completed within the time duration of 6 month. Sample size of twenty four patient consists of both male and female aged between 50 years to 75 years. Each group contain 12 patient .Group A was experimental group which received balance exercise in two phases and group B (n=12) was control group received conventional therapy. Each of exercise program begun with 10 mints warm up consisting of walking ad light stretching of hip flexor. The balance training group received the balance training exercise twice a week for 6 week each session comprise of 60 minutes. Each set consisted of 4 periods of 11 exercises and rest of 40 seconds. Many exercises over time was turned into circuit training. Data was analyzed by using SPSS version 23.
Read the detailed description
Stroke is a global health-care problem that is common, serious, and disabling in most countries, the 2nd or 3rd most common cause of death and one of the main causes of acquired adult disability. Patients with stroke have number of impairments but usually present with difficulty maintaining balance. Balance is described as the ability to maintain equilibrium in a gravitational field by keeping or returning the center of body mass over its base of support. Body balance is the result of a harmonious interaction between the afferents from sensory systems (vestibular, proprioceptive and visual). The somatosensory system organizes proprioceptive information, while the visual system provides information about the position of the body in relation to the external environment. When the functions of the sensory triad are disrupted, unpleasant sensations occur, e.g. dizziness, nausea, feeling of imbalance and, sometimes, nystagmus, Balance is a complex process in which the maintenance of a position is regulated by postural adjustments to voluntary activity and in response to external perturbation. Impairments of postural control result in increased rates of unintentional falls. In fact, falls are the leading cause of injuries and subsequent deaths among people 65 years and older, and generate a fundamental financial burden to the healthcare system.Stroke survivors present with deficits in different systems, including sensory, musculoskeletal, perceptual, and cognitive, which decrease postural stability. The lack of postural stability can lead to falls during hospitalization, both in the acute care and rehabilitation stages, and after discharge. Because of the importance of postural instability in this population, a systematic evaluation of balance is needed to identify specific problems.The measures most commonly used with stroke patients are different parameters extracted from the center of pressure (COP) and weight distribution of the vertical reaction force. After a stroke, patients have demonstrated a significant increase in sway and weight-bearing asymmetry. The relearning of postural control through external visual and auditory biofeedback is believed to be an effective therapy for improving balance control. In a Cochrane review, the results of seven randomized clinical trials and indicated that providing feedback from a force platform resulted in improved stance symmetry after stroke but did not improve balance during active functional activities, nor did it improve overall independence. A study conducted on elderly population was concluded that Balance training reduced elderly subjects' overactive proprioceptive feedback and enhanced vestibular orientation Previous studies only assess the effect of balance training on elderly population or stroke population. But the role of these trainings on vestibular and proprioception function were not assessed among stoke population while in the current study we aimed to assess the effect of balance training of simple physical therapy exercises on sensory channel (vestibular function, proprioception feedback mainly). In 2011 on Stroke rehabilitation was concluded by Ongoing trials of repetitive task training, early mobilization, treadmill training, physical fitness training, and speech and language training for aphasia and dysarthria are high-quality, multicenter, multidisciplinary studies of complex interventions, which meet many of the above recommendations.
In 2004 a comparative study to compare clinical and biomechanical measures of balance in elderly stroke patients with those of healthy elderly people. This study concluded as postural stability in quiet stance, as measured by COP-COM amplitude, was related to functional measures of balance as well as physiologic factors relating to balance, such as visual conditions, lower-extremity peripheral sensibility, motor recovery, and simple reaction time Another study on dynamic balance ability through stair gait training where in proprioceptive neuromuscular facilitation (PNF) was applied and for the four weeks of the experiment, each group received training three times per week, for 30 min each time. Berg Balance Scale (BBS) values were measured and a time up and go (TUG) test and a functional reach test (FRT) were performed for a comparison before and after the experiment which is concluded that gait training group to which PNF was applied saw improvements in their balance ability, and a good result is expected when neurological disease patients receive stair gait training applying PNF.(10) A systematic review evaluated recent evidence related to the effect of balance training on balance performance among individuals post stroke across the continuum of recovery. On the basis of this evidence, we also provide recommendations for exercise prescription in such programs. Review evaluated recent evidence related to the effect of balance training on balance performance among individuals post stroke across the continuum of recovery. On the basis of this evidence, we also provide recommendations for exercise prescription in such programs.
In 2o18 on to investigate the effect of customized vestibular rehabilitation training on gait stability of patients with sub-acute stroke. An instrumented 10- Meter Walk Test together with traditional clinical scales were used to assess VR effects. Which is concluded by VR could be included into a rehabilitation program for patients with stroke for improving their gait and dynamic balance acting on their vestibular system as facilitator of recovery.
Another study in 2014 virtual reality (VR) proprioception rehabilitation system was developed for stroke patients to use proprioception feedback in upper limb rehabilitation by blocking visual feedback. To evaluate its therapeutic effect, 10 stroke patients (onset > 3 month) trained proprioception feedback rehabilitation for one week and visual feedback rehabilitation for another week in random order. Proprioception functions were checked before, a week after, and at the end of training.it was concluded that effectiveness and possible use of the VR to recover the proprioception of stroke patients In 2020 A pilot study to find out the effects of COP (center of pressure) movement tracking training conducted using the Biodex Balance System SD in static and dynamic modes on balance ability in stroke patients. The result of study concluded that COP movement tracking training in dynamic mode was found to be a more effective intervention for improving the static balancing abilities of stroke patients than training in static mode.
In 2000 A comparative study was done by walker et al to compared the relative effectiveness of visual feedback training of center-of-gravity (COG) positioning with conventional physical therapy following acute stroke result show that Visual feedback or conventional balance training in addition to regular therapy affords no added benefit when offered in the early stages of rehabilitation following stroke
- Conditions
- Stroke, Ischemic
- Being tested
- Traditional physical therapy balance exercise, proprioception based balance training
- Keywords
- Balance training, Stroke, Proprioceptive feedback, Vestibular function
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional physical therapy balance exerciseOther
first phase : stepping forward, backward, and sideways on the exercise step stepping over blocks of various heights standing up from a chair, walking four steps forward,)A performing a range of motion and balance exercises (forward and backward rolling of the arms; bending the trunk forward and side to side);on a swiss ball. performed In a normal condition In first 20 m of each session 2nd phase Performing double-legged stance tandem walking forward and backward
- Dosage of exercise was twice a week for 6 week each session comprise of 60 mints. Each set consisted of 4 periods of 11 exercises and rest of 40 sec .many exercise over time will turn into circuit training
proprioception based balance trainingOther
first phase : stepping forward, backward, and sideways on the exercise step stepping over blocks of various heights standing up from a chair, walking four steps forward,)A performing a range of motion and balance exercises (forward and backward rolling of the arms; bending the trunk forward and side to side);on a swiss ball. performed In a normal condition In first 20 m of each session 2nd phase Performing double-legged stance tandem walking forward and backward all exercise done under following condition.
- eyes open firm surfaces
- Eyes open soft surfaces
- Eyes closed firm surfaces
- Eyes closed soft surfaces (the soft surfaces will be a foam mate with 2.5 cm thick )
- These exercise will perform with turning the head side to side ad up and down
- Dosage of exercise was twice a week for 6 week each session comprise of 60 mints. Each set consisted of 4 periods of 11 exercises and rest of 40 sec .many exercise over time will turn into circuit training
| Study group | Role | What they receive |
|---|---|---|
| Traditional physical therapy balance exercise | Active comparator | Traditional physical therapy including balance exercise on mate and swiss ball. Receives: Other: Traditional physical therapy balance exercise |
| proprioception based balance training | Experimental | proprioception based balance training with eye open and close on soft , firm and foam surface. Receives: Other: proprioception based balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fukuda stepping test
Changes from the baseline, It is neurological test to test vestibular function. Patient was asked to take 50 steps withy eyes closed in circle. After 50nsteps angle and distance measured from the initial to terminal position.
Measured: 6 week
Berg Balance Scale
Changes from the baseline, The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. A score of 56 indicates functional balance.A score of < 45 indicates individuals may be at greater risk of falling
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start20 Feb 2020
- Primary completion20 Aug 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies 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
- parallel assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binash Afzal, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557839
- Sponsor's protocol ID
- REC/20/2050 Asia bashir
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pimentel BN, Filha VAVDS. Evaluation of vestibular and oculomotor functions in individuals with dizziness after stroke. Arq Neuropsiquiatr. 2019 Jan;77(1):25-32. doi: 10.1590/0004-282X20180154.
PubMed 30758439Wiesmeier IK, Dalin D, Wehrle A, Granacher U, Muehlbauer T, Dietterle J, Weiller C, Gollhofer A, Maurer C. Balance Training Enhances Vestibular Function and Reduces Overactive Proprioceptive Feedback in Elderly. Front Aging Neurosci. 2017 Aug 11;9:273. doi: 10.3389/fnagi.2017.00273. eCollection 2017.
PubMed 28848430Corriveau H, Hebert R, Raiche M, Prince F. Evaluation of postural stability in the elderly with stroke. Arch Phys Med Rehabil. 2004 Jul;85(7):1095-101. doi: 10.1016/j.apmr.2003.09.023.
PubMed 15241756Barclay-Goddard R, Stevenson T, Poluha W, Moffatt ME, Taback SP. Force platform feedback for standing balance training after stroke. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD004129. doi: 10.1002/14651858.CD004129.pub2.
PubMed 15495079Yavuzer G, Eser F, Karakus D, Karaoglan B, Stam HJ. The effects of balance training on gait late after stroke: a randomized controlled trial. Clin Rehabil. 2006 Nov;20(11):960-9. doi: 10.1177/0269215506070315.
PubMed 17065539Seo K, Park SH, Park K. The effects of stair gait training using proprioceptive neuromuscular facilitation on stroke patients' dynamic balance ability. J Phys Ther Sci. 2015 May;27(5):1459-62. doi: 10.1589/jpts.27.1459. Epub 2015 May 26.
PubMed 26157240Lubetzky-Vilnai A, Kartin D. The effect of balance training on balance performance in individuals poststroke: a systematic review. J Neurol Phys Ther. 2010 Sep;34(3):127-37. doi: 10.1097/NPT.0b013e3181ef764d.
PubMed 20716987Tramontano M, Bergamini E, Iosa M, Belluscio V, Vannozzi G, Morone G. Vestibular rehabilitation training in patients with subacute stroke: A preliminary randomized controlled trial. NeuroRehabilitation. 2018;43(2):247-254. doi: 10.3233/NRE-182427.
PubMed 30040765Cho S, Ku J, Cho YK, Kim IY, Kang YJ, Jang DP, Kim SI. Development of virtual reality proprioceptive rehabilitation system for stroke patients. Comput Methods Programs Biomed. 2014;113(1):258-65. doi: 10.1016/j.cmpb.2013.09.006. Epub 2013 Sep 19.
PubMed 24183070Cha JH, Kim NH, Cha YJ. Effect of proprioceptive stimulation induced by footplate during center of pressure movement tracking training on the balance abilities of patients with chronic hemiplegic stroke: a randomized, controlled, pilot study. Top Stroke Rehabil. 2020 Jan;27(1):38-43. doi: 10.1080/10749357.2019.1661699. Epub 2019 Sep 4.
PubMed 31480897Smania N, Picelli A, Gandolfi M, Fiaschi A, Tinazzi M. Rehabilitation of sensorimotor integration deficits in balance impairment of patients with stroke hemiparesis: a before/after pilot study. Neurol Sci. 2008 Oct;29(5):313-9. doi: 10.1007/s10072-008-0988-0. Epub 2008 Oct 21.
PubMed 18941933Mao Y, Chen P, Li L, Huang D. Virtual reality training improves balance function. Neural Regen Res. 2014 Sep 1;9(17):1628-34. doi: 10.4103/1673-5374.141795.
PubMed 25368651Walker C, Brouwer BJ, Culham EG. Use of visual feedback in retraining balance following acute stroke. Phys Ther. 2000 Sep;80(9):886-95.
PubMed 10960936Chen IC, Cheng PT, Chen CL, Chen SC, Chung CY, Yeh TH. Effects of balance training on hemiplegic stroke patients. Chang Gung Med J. 2002 Sep;25(9):583-90.
PubMed 12479619Donath L, Roth R, Zahner L, Faude O. Slackline Training (Balancing Over Narrow Nylon Ribbons) and Balance Performance: A Meta-Analytical Review. Sports Med. 2017 Jun;47(6):1075-1086. doi: 10.1007/s40279-016-0631-9.
PubMed 27704483
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Balance Training on Vestibular Function and Proprioception Feedback in Stroke Patient
- ClinicalTrials.gov ID
- NCT04557839
- Acronym / sponsor ID
- REC/20/2050 Asia bashir
- Conditions
- Stroke, Ischemic
- Keywords
- Balance training, Stroke, Proprioceptive feedback, Vestibular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 22 Sep 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.
The aim of this study was to find out the role of balance training on vestibular function and proprioception feedback in stroke patients. It was a randomized control trial and was conducted in civil hospital Gujranwala. Current study was completed within the time duration of 6 month. Sample size of twenty four patient consists of both male and female aged between 50 years to 75 years. Each group contain 12 patient .Group A was experimental group which received balance exercise in two phases and group B (n=12) was control group received conventional therapy. Each of exercise program begun with 10 mints warm up consisting of walking ad light stretching of hip flexor. The balance training group received the balance training exercise twice a week for 6 week each session comprise of 60 minutes. Each set consisted of 4 periods of 11 exercises and rest of 40 seconds. Many exercises over time was turned into circuit training. Data was analyzed by using SPSS version 23.
Detailed description
Stroke is a global health-care problem that is common, serious, and disabling in most countries, the 2nd or 3rd most common cause of death and one of the main causes of acquired adult disability. Patients with stroke have number of impairments but usually present with difficulty maintaining balance. Balance is described as the ability to maintain equilibrium in a gravitational field by keeping or returning the center of body mass over its base of support. Body balance is the result of a harmonious interaction between the afferents from sensory systems (vestibular, proprioceptive and visual). The somatosensory system organizes proprioceptive information, while the visual system provides information about the position of the body in relation to the external environment. When the functions of the sensory triad are disrupted, unpleasant sensations occur, e.g. dizziness, nausea, feeling of imbalance and, sometimes, nystagmus, Balance is a complex process in which the maintenance of a position is regulated by postural adjustments to voluntary activity and in response to external perturbation. Impairments of postural control result in increased rates of unintentional falls. In fact, falls are the leading cause of injuries and subsequent deaths among people 65 years and older, and generate a fundamental financial burden to the healthcare system.Stroke survivors present with deficits in different systems, including sensory, musculoskeletal, perceptual, and cognitive, which decrease postural stability. The lack of postural stability can lead to falls during hospitalization, both in the acute care and rehabilitation stages, and after discharge. Because of the importance of postural instability in this population, a systematic evaluation of balance is needed to identify specific problems.The measures most commonly used with stroke patients are different parameters extracted from the center of pressure (COP) and weight distribution of the vertical reaction force. After a stroke, patients have demonstrated a significant increase in sway and weight-bearing asymmetry. The relearning of postural control through external visual and auditory biofeedback is believed to be an effective therapy for improving balance control. In a Cochrane review, the results of seven randomized clinical trials and indicated that providing feedback from a force platform resulted in improved stance symmetry after stroke but did not improve balance during active functional activities, nor did it improve overall independence. A study conducted on elderly population was concluded that Balance training reduced elderly subjects' overactive proprioceptive feedback and enhanced vestibular orientation Previous studies only assess the effect of balance training on elderly population or stroke population. But the role of these trainings on vestibular and proprioception function were not assessed among stoke population while in the current study we aimed to assess the effect of balance training of simple physical therapy exercises on sensory channel (vestibular function, proprioception feedback mainly). In 2011 on Stroke rehabilitation was concluded by Ongoing trials of repetitive task training, early mobilization, treadmill training, physical fitness training, and speech and language training for aphasia and dysarthria are high-quality, multicenter, multidisciplinary studies of complex interventions, which meet many of the above recommendations.
In 2004 a comparative study to compare clinical and biomechanical measures of balance in elderly stroke patients with those of healthy elderly people. This study concluded as postural stability in quiet stance, as measured by COP-COM amplitude, was related to functional measures of balance as well as physiologic factors relating to balance, such as visual conditions, lower-extremity peripheral sensibility, motor recovery, and simple reaction time Another study on dynamic balance ability through stair gait training where in proprioceptive neuromuscular facilitation (PNF) was applied and for the four weeks of the experiment, each group received training three times per week, for 30 min each time. Berg Balance Scale (BBS) values were measured and a time up and go (TUG) test and a functional reach test (FRT) were performed for a comparison before and after the experiment which is concluded that gait training group to which PNF was applied saw improvements in their balance ability, and a good result is expected when neurological disease patients receive stair gait training applying PNF.(10) A systematic review evaluated recent evidence related to the effect of balance training on balance performance among individuals post stroke across the continuum of recovery. On the basis of this evidence, we also provide recommendations for exercise prescription in such programs. Review evaluated recent evidence related to the effect of balance training on balance performance among individuals post stroke across the continuum of recovery. On the basis of this evidence, we also provide recommendations for exercise prescription in such programs.
In 2o18 on to investigate the effect of customized vestibular rehabilitation training on gait stability of patients with sub-acute stroke. An instrumented 10- Meter Walk Test together with traditional clinical scales were used to assess VR effects. Which is concluded by VR could be included into a rehabilitation program for patients with stroke for improving their gait and dynamic balance acting on their vestibular system as facilitator of recovery.
Another study in 2014 virtual reality (VR) proprioception rehabilitation system was developed for stroke patients to use proprioception feedback in upper limb rehabilitation by blocking visual feedback. To evaluate its therapeutic effect, 10 stroke patients (onset > 3 month) trained proprioception feedback rehabilitation for one week and visual feedback rehabilitation for another week in random order. Proprioception functions were checked before, a week after, and at the end of training.it was concluded that effectiveness and possible use of the VR to recover the proprioception of stroke patients In 2020 A pilot study to find out the effects of COP (center of pressure) movement tracking training conducted using the Biodex Balance System SD in static and dynamic modes on balance ability in stroke patients. The result of study concluded that COP movement tracking training in dynamic mode was found to be a more effective intervention for improving the static balancing abilities of stroke patients than training in static mode.
In 2000 A comparative study was done by walker et al to compared the relative effectiveness of visual feedback training of center-of-gravity (COG) positioning with conventional physical therapy following acute stroke result show that Visual feedback or conventional balance training in addition to regular therapy affords no added benefit when offered in the early stages of rehabilitation following stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Traditional physical therapy balance exercise | Active comparator | Other: Traditional physical therapy balance exerciseTraditional physical therapy including balance exercise on mate and swiss ball. |
| proprioception based balance training | Experimental | Other: proprioception based balance trainingproprioception based balance training with eye open and close on soft , firm and foam surface. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with impaired balance ,vestibular function and proprioception due to stroke
- Victim of a stroke that resulted in hemiparesis,
- Be at least 6 months
- Be fully discharged from all rehabilitation program
Key exclusion criteria (6 listed)
- Those with recurrent strokes
- Bilateral hemispheric cerebellar or brain stem lesions
- Severe spasticity or cognitive deficit
- Orthopedic or peripheral neuropathy
- Significant visual field or hemi neglect problems were excluded.
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 |
|---|---|---|
| Traditional physical therapy balance exercisefirst phase : stepping forward, backward, and sideways on the exercise step stepping over blocks of various heights standing up from a chair, walking four steps forward,)A performing a range of motion and balance exercises (forward and backward rolling of the arms; bending the trunk forward and side to side);on a swiss ball. performed In a normal condition In first 20 m of each session 2nd phase Performing double-legged stance tandem walking forward and backward • Dosage of exercise was twice a week for 6 week each session comprise of 60 mints. Each set consisted of 4 periods of 11 exercises and rest of 40 sec .many exercise over time will turn into circuit training | Other | Traditional physical therapy balance exercise |
| proprioception based balance trainingfirst phase : stepping forward, backward, and sideways on the exercise step stepping over blocks of various heights standing up from a chair, walking four steps forward,)A performing a range of motion and balance exercises (forward and backward rolling of the arms; bending the trunk forward and side to side);on a swiss ball. performed In a normal condition In first 20 m of each session 2nd phase Performing double-legged stance tandem walking forward and backward all exercise done under following condition. * eyes open firm surfaces * Eyes open soft surfaces * Eyes closed firm surfaces * Eyes closed soft surfaces (the soft surfaces will be a foam mate with 2.5 cm thick ) * These exercise will perform with turning the head side to side ad up and down * Dosage of exercise was twice a week for 6 week each session comprise of 60 mints. Each set consisted of 4 periods of 11 exercises and rest of 40 sec .many exercise over time will turn into circuit training | Other | proprioception based balance training |
Primary outcome
Fukuda stepping test
Time frame: 6 week
Changes from the baseline, It is neurological test to test vestibular function. Patient was asked to take 50 steps withy eyes closed in circle. After 50nsteps angle and distance measured from the initial to terminal position.
Berg Balance Scale
Time frame: 6 week
Changes from the baseline, The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. A score of 56 indicates functional balance.A score of < 45 indicates individuals may be at greater risk of falling
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 22 Sep 2020.
- Background: PubMed 30758439Pimentel BN, Filha VAVDS. Evaluation of vestibular and oculomotor functions in individuals with dizziness after stroke. Arq Neuropsiquiatr. 2019 Jan;77(1):25-32. doi: 10.1590/0004-282X20180154.
- Background: PubMed 28848430Wiesmeier IK, Dalin D, Wehrle A, Granacher U, Muehlbauer T, Dietterle J, Weiller C, Gollhofer A, Maurer C. Balance Training Enhances Vestibular Function and Reduces Overactive Proprioceptive Feedback in Elderly. Front Aging Neurosci. 2017 Aug 11;9:273. doi: 10.3389/fnagi.2017.00273. eCollection 2017.
- Background: PubMed 15241756Corriveau H, Hebert R, Raiche M, Prince F. Evaluation of postural stability in the elderly with stroke. Arch Phys Med Rehabil. 2004 Jul;85(7):1095-101. doi: 10.1016/j.apmr.2003.09.023.
- Background: PubMed 15495079Barclay-Goddard R, Stevenson T, Poluha W, Moffatt ME, Taback SP. Force platform feedback for standing balance training after stroke. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD004129. doi: 10.1002/14651858.CD004129.pub2.
- Background: PubMed 17065539Yavuzer G, Eser F, Karakus D, Karaoglan B, Stam HJ. The effects of balance training on gait late after stroke: a randomized controlled trial. Clin Rehabil. 2006 Nov;20(11):960-9. doi: 10.1177/0269215506070315.
- Background: PubMed 26157240Seo K, Park SH, Park K. The effects of stair gait training using proprioceptive neuromuscular facilitation on stroke patients' dynamic balance ability. J Phys Ther Sci. 2015 May;27(5):1459-62. doi: 10.1589/jpts.27.1459. Epub 2015 May 26.
- Background: PubMed 20716987Lubetzky-Vilnai A, Kartin D. The effect of balance training on balance performance in individuals poststroke: a systematic review. J Neurol Phys Ther. 2010 Sep;34(3):127-37. doi: 10.1097/NPT.0b013e3181ef764d.
- Background: PubMed 30040765Tramontano M, Bergamini E, Iosa M, Belluscio V, Vannozzi G, Morone G. Vestibular rehabilitation training in patients with subacute stroke: A preliminary randomized controlled trial. NeuroRehabilitation. 2018;43(2):247-254. doi: 10.3233/NRE-182427.
- Background: PubMed 24183070Cho S, Ku J, Cho YK, Kim IY, Kang YJ, Jang DP, Kim SI. Development of virtual reality proprioceptive rehabilitation system for stroke patients. Comput Methods Programs Biomed. 2014;113(1):258-65. doi: 10.1016/j.cmpb.2013.09.006. Epub 2013 Sep 19.
- Background: PubMed 31480897Cha JH, Kim NH, Cha YJ. Effect of proprioceptive stimulation induced by footplate during center of pressure movement tracking training on the balance abilities of patients with chronic hemiplegic stroke: a randomized, controlled, pilot study. Top Stroke Rehabil. 2020 Jan;27(1):38-43. doi: 10.1080/10749357.2019.1661699. Epub 2019 Sep 4.
- Background: PubMed 18941933Smania N, Picelli A, Gandolfi M, Fiaschi A, Tinazzi M. Rehabilitation of sensorimotor integration deficits in balance impairment of patients with stroke hemiparesis: a before/after pilot study. Neurol Sci. 2008 Oct;29(5):313-9. doi: 10.1007/s10072-008-0988-0. Epub 2008 Oct 21.
- Background: PubMed 25368651Mao Y, Chen P, Li L, Huang D. Virtual reality training improves balance function. Neural Regen Res. 2014 Sep 1;9(17):1628-34. doi: 10.4103/1673-5374.141795.
- Individual participant dataSharing planned: No
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Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Recruiting
Safety and Feasibility of NRICM301 Added to Usual Care for Adults With Acute Ischemic Stroke
Acute Ischemic Stroke
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.
Binash Afzal, 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 Traditional physical therapy balance exercise and proprioception based balance training in people with Stroke, Ischemic, 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 4 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 22 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?
Fukuda stepping test (time frame: 6 week). The study lists 2 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 NCT04557839, which also lists 15 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 22 Sep 2020.