StrokeNCT05411653
Xbox Kinect Virtual Reality and Motor Imagery on Lower Limb Function in Chronic Stroke Patients
A study testing Virtual reality training with motor imagery and Conventional physical therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
As virtual reality has therapeutic benefits and improves motor learning by practicing exercises in environment that analogue and mimic occasions and events of real world, as VR is designed and tailored according to the need of patient so it may address the individual issues whereas motor imagery uses explicit learning… Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual reality training with motor imagery and Conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Mar 2022to 24 Feb 2023
- 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 who are 45-65 years of age
- Participants who have had their first stroke attack at least 6 months prior
- A score of 21 or greater on the Mini-Mental State Examination (MMSE)
- Participants who were not diagnosed with visual or auditory issues
- Volunteers should be able to walk at least 10 meters with or without assistive devices
- The patient shouldn't be taking any medicine that can have an impact on the gait or balance.
Who cannot join
- Patients younger than 45 years of age.
- Patients suffering from any condition that requires medical attention such as uncontrolled blood pressure or angina.
- Musculoskeletal impairments of the lower extremity.
- Patients with psychological or neurological problems other than stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effects of Xbox Kinect Virtual Reality and Motor Imagery on Lower Limb Function, Dynamic Balance and Gait in Chronic Stroke Patients
As virtual reality has therapeutic benefits and improves motor learning by practicing exercises in environment that analogue and mimic occasions and events of real world, as VR is designed and tailored according to the need of patient so it may address the individual issues whereas motor imagery uses explicit learning process for muscle activation and movement. Therefore their combination may yield better outcomes in terms of lower limb function and dynamic mobility, so there is a need to assess the combined effects of Xbox kinect gaming with motor imagery in chronic stroke patients.
Read the detailed description
Stroke is focal neurological disorder that occurs due to the compromised blood flow to the brain. It results in mobility deficit, functional and gait impairment. Multiple rehabilitation methods have been designed and used, motor imagery (MI) and virtual reality (VR) are among the emerging techniques that are being used for the rehabilitation of patients with neurological conditions that improve motor learning through explicit and implicit processes.
After stroke the residual symptoms such as muscle hyper tonicity, attention deficiency, hemi neglect, abnormal reflexes and sensorimotor functional impairment may persist. Additional to these neurological symptoms certain balance issues may cause decrease in proprioception, muscle strength, increased load on non-paretic extremity and postural oscillations. It has been reported that every year approximately 25.7 million people survive stroke attacks, 6.5 million die because of stroke and 113 million people have disability-adjusted life-years.
Kinect based rehabilitation and virtual feedback have shown relevant activation changes in the primary sensorimotor cortex and can be responsible for that part of brain reorganization for improving in upper limb in stroke patients. Use of exer gaming is one of the emerging technologies that are being used for the physical, cognitive and motor rehabilitation of stroke patients. It is combination of video games and motion sensors incorporated in a virtual reality environment that engage the patients and improves motor learning therefore activating the motor areas of the brain for long term results.
Non immersive virtual reality gaming has been used for improving balance among the stroke patients. Not only is it considered more beneficial as compared to the conventional therapies but also maintains the interest of patients in their rehabilitation protocol. The Kinect based games use sensors that catch movements of the patients and they are able to watch them in real time with immediate feedback that becomes a source of motivation for them.
Xbox Kinect virtual gaming creates 3D environment with sensors and requires no controllers for patients to perform exercise whereas motor imagery is a state in which a particular motor action is internally activated without any motor output. Not only is VR and MI training motivating as compare to conventional therapies but also provide positive learning experience and neuroplasticity. With xbox kinect based VR therapies and MI, the exercise plan is tailored according to the needs of the patient.
It will be a single blinded randomized control trial in which control group will be given conventional physiotherapy protocol for 30 minutes and experimental group will receive the VR and MI training with conventional treatment for a total 60 minutes, 3 days a week for 6 weeks. Motor function will be assessed by fugl-meyer scale (LE), dynamic mobility by berg balance scale and 6 minute walk test, quality of life by barthel index and gait with dynamic gait index. Patient will be assessed at baseline and at the end of six weeks. The data will be analyzed using SPSS 25 software.
- Conditions
- Stroke
- Being tested
- Virtual reality training with motor imagery, Conventional physical therapy
- Keywords
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality training with motor imageryOther
comprised of 30 minutes, VRT (15 minutes) and MI (15 minutes) daily for 3 days respectively. Five Xbox Kinect gaming will be selected and explained to the patients for the virtual training session and additional 15 minutes will be given to them for practice. The games consists of 20,000 water leaks, river rush, reflex ridge, soccer and football for the patients.
Conventional physical therapyOther
range of motion exercises, muscle strengthening, functional training, balance training, and gait training. The specific tasks will be selected by the therapist based on the requirement of each patient. It will be performed for 30 minutes for 3 days a week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality training with motor imagery | Experimental | Xbox Kinect VR with MI training Five Xbox Kinect gaming will be selected and explained to the patients for the virtual training session Receives: Other: Virtual reality training with motor imagery |
| Conventional physical therapy | Active comparator | a range of motion exercises, muscle strengthening, functional training, balance training, and gait training. T Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Gait Index DGI
Clinical tool to assess gait, balance and fall risk. It evaluates not only usual steady-state walking, but also walking during more challenging tasks
Measured: 6th week
Berg Balance Scale BBS
Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
Measured: 6th week
Fugl-Meyer Scale for lower extremity
This clinical tool is for assessment of lower limb function. It is a reliable and valid tool. Interrater and intrarater reliability coefficients are reported to be >0.85 for both upper and lower limb) the domain subscales and the entire scale.
Measured: 6th week
Six Minute Walk Test
It is used to assess aerobic capacity and endurance.
Measured: 6th week
Secondary outcomes (1)
Barthel index
It is functional independence measure.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start4 Mar 2022
- Primary completion24 Jan 2023
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 26 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 lahore campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411653
- Sponsor's protocol ID
- REC/RCR&AHS/22/0213
- Status last verified
- Jan 2024
- First submitted
- 6 Jun 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee HC, Huang CL, Ho SH, Sung WH. The Effect of a Virtual Reality Game Intervention on Balance for Patients with Stroke: A Randomized Controlled Trial. Games Health J. 2017 Oct;6(5):303-311. doi: 10.1089/g4h.2016.0109. Epub 2017 Aug 3.
PubMed 28771379Aslam M, Ain QU, Fayyaz P, Malik AN. Exer-gaming reduces fall risk and improves mobility after stroke. J Pak Med Assoc. 2021 Jun;71(6):1673-1675. doi: 10.47391/JPMA.875.
PubMed 34111095Bao X, Mao Y, Lin Q, Qiu Y, Chen S, Li L, Cates RS, Zhou S, Huang D. Mechanism of Kinect-based virtual reality training for motor functional recovery of upper limbs after subacute stroke. Neural Regen Res. 2013 Nov 5;8(31):2904-13. doi: 10.3969/j.issn.1673-5374.2013.31.003.
PubMed 25206611Silva S, Borges LR, Santiago L, Lucena L, Lindquist AR, Ribeiro T. Motor imagery for gait rehabilitation after stroke. Cochrane Database Syst Rev. 2020 Sep 24;9(9):CD013019. doi: 10.1002/14651858.CD013019.pub2.
PubMed 32970328Bovonsunthonchai S, Aung N, Hiengkaew V, Tretriluxana J. A randomized controlled trial of motor imagery combined with structured progressive circuit class therapy on gait in stroke survivors. Sci Rep. 2020 Apr 24;10(1):6945. doi: 10.1038/s41598-020-63914-8.
PubMed 32332810Lin RC, Chiang SL, Heitkemper MM, Weng SM, Lin CF, Yang FC, Lin CH. Effectiveness of Early Rehabilitation Combined With Virtual Reality Training on Muscle Strength, Mood State, and Functional Status in Patients With Acute Stroke: A Randomized Controlled Trial. Worldviews Evid Based Nurs. 2020 Apr;17(2):158-167. doi: 10.1111/wvn.12429. Epub 2020 Mar 25.
PubMed 32212254Askin A, Atar E, Kocyigit H, Tosun A. Effects of Kinect-based virtual reality game training on upper extremity motor recovery in chronic stroke. Somatosens Mot Res. 2018 Mar;35(1):25-32. doi: 10.1080/08990220.2018.1444599. Epub 2018 Mar 13.
PubMed 29529919Malik AN, Masood T. Effects of virtual reality training on mobility and physical function in stroke. J Pak Med Assoc. 2017 Oct;67(10):1618-1620.
PubMed 28955088Chanpimol S, Seamon B, Hernandez H, Harris-Love M, Blackman MR. Using Xbox kinect motion capture technology to improve clinical rehabilitation outcomes for balance and cardiovascular health in an individual with chronic TBI. Arch Physiother. 2017;7:6. doi: 10.1186/s40945-017-0033-9. Epub 2017 May 31.
PubMed 28824816In T, Lee K, Song C. Virtual Reality Reflection Therapy Improves Balance and Gait in Patients with Chronic Stroke: Randomized Controlled Trials. Med Sci Monit. 2016 Oct 28;22:4046-4053. doi: 10.12659/msm.898157.
PubMed 27791207Im H, Ku J, Kim HJ, Kang YJ. Virtual Reality-Guided Motor Imagery Increases Corticomotor Excitability in Healthy Volunteers and Stroke Patients. Ann Rehabil Med. 2016 Jun;40(3):420-31. doi: 10.5535/arm.2016.40.3.420. Epub 2016 Jun 29.
PubMed 27446778Gibbons EM, Thomson AN, de Noronha M, Joseph S. Are virtual reality technologies effective in improving lower limb outcomes for patients following stroke - a systematic review with meta-analysis. Top Stroke Rehabil. 2016 Dec;23(6):440-457. doi: 10.1080/10749357.2016.1183349. Epub 2016 May 30.
PubMed 27237336Bae YH, Ko Y, Ha H, Ahn SY, Lee W, Lee SM. An efficacy study on improving balance and gait in subacute stroke patients by balance training with additional motor imagery: a pilot study. J Phys Ther Sci. 2015 Oct;27(10):3245-8. doi: 10.1589/jpts.27.3245. Epub 2015 Oct 30.
PubMed 26644684Park DS, Lee DG, Lee K, Lee G. Effects of Virtual Reality Training using Xbox Kinect on Motor Function in Stroke Survivors: A Preliminary Study. J Stroke Cerebrovasc Dis. 2017 Oct;26(10):2313-2319. doi: 10.1016/j.jstrokecerebrovasdis.2017.05.019. Epub 2017 Jun 9.
PubMed 28606661
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Xbox Kinect Virtual Reality and Motor Imagery on Lower Limb Function, Dynamic Balance and Gait in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05411653
- Acronym / sponsor ID
- REC/RCR&AHS/22/0213
- Conditions
- Stroke
- Keywords
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 9 Jun 2022 (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.
As virtual reality has therapeutic benefits and improves motor learning by practicing exercises in environment that analogue and mimic occasions and events of real world, as VR is designed and tailored according to the need of patient so it may address the individual issues whereas motor imagery uses explicit learning process for muscle activation and movement. Therefore their combination may yield better outcomes in terms of lower limb function and dynamic mobility, so there is a need to assess the combined effects of Xbox kinect gaming with motor imagery in chronic stroke patients.
Detailed description
Stroke is focal neurological disorder that occurs due to the compromised blood flow to the brain. It results in mobility deficit, functional and gait impairment. Multiple rehabilitation methods have been designed and used, motor imagery (MI) and virtual reality (VR) are among the emerging techniques that are being used for the rehabilitation of patients with neurological conditions that improve motor learning through explicit and implicit processes.
After stroke the residual symptoms such as muscle hyper tonicity, attention deficiency, hemi neglect, abnormal reflexes and sensorimotor functional impairment may persist. Additional to these neurological symptoms certain balance issues may cause decrease in proprioception, muscle strength, increased load on non-paretic extremity and postural oscillations. It has been reported that every year approximately 25.7 million people survive stroke attacks, 6.5 million die because of stroke and 113 million people have disability-adjusted life-years.
Kinect based rehabilitation and virtual feedback have shown relevant activation changes in the primary sensorimotor cortex and can be responsible for that part of brain reorganization for improving in upper limb in stroke patients. Use of exer gaming is one of the emerging technologies that are being used for the physical, cognitive and motor rehabilitation of stroke patients. It is combination of video games and motion sensors incorporated in a virtual reality environment that engage the patients and improves motor learning therefore activating the motor areas of the brain for long term results.
Non immersive virtual reality gaming has been used for improving balance among the stroke patients. Not only is it considered more beneficial as compared to the conventional therapies but also maintains the interest of patients in their rehabilitation protocol. The Kinect based games use sensors that catch movements of the patients and they are able to watch them in real time with immediate feedback that becomes a source of motivation for them.
Xbox Kinect virtual gaming creates 3D environment with sensors and requires no controllers for patients to perform exercise whereas motor imagery is a state in which a particular motor action is internally activated without any motor output. Not only is VR and MI training motivating as compare to conventional therapies but also provide positive learning experience and neuroplasticity. With xbox kinect based VR therapies and MI, the exercise plan is tailored according to the needs of the patient.
It will be a single blinded randomized control trial in which control group will be given conventional physiotherapy protocol for 30 minutes and experimental group will receive the VR and MI training with conventional treatment for a total 60 minutes, 3 days a week for 6 weeks. Motor function will be assessed by fugl-meyer scale (LE), dynamic mobility by berg balance scale and 6 minute walk test, quality of life by barthel index and gait with dynamic gait index. Patient will be assessed at baseline and at the end of six weeks. The data will be analyzed using SPSS 25 software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality training with motor imagery | Experimental | Other: Virtual reality training with motor imageryXbox Kinect VR with MI training Five Xbox Kinect gaming will be selected and explained to the patients for the virtual training session |
| Conventional physical therapy | Active comparator | Other: Conventional physical therapya range of motion exercises, muscle strengthening, functional training, balance training, and gait training. T |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants who are 45-65 years of age
- Participants who have had their first stroke attack at least 6 months prior
- A score of 21 or greater on the Mini-Mental State Examination (MMSE)
- Participants who were not diagnosed with visual or auditory issues
- Volunteers should be able to walk at least 10 meters with or without assistive devices
Key exclusion criteria (4 listed)
- Patients younger than 45 years of age.
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 |
|---|---|---|
| Virtual reality training with motor imagerycomprised of 30 minutes, VRT (15 minutes) and MI (15 minutes) daily for 3 days respectively. Five Xbox Kinect gaming will be selected and explained to the patients for the virtual training session and additional 15 minutes will be given to them for practice. The games consists of 20,000 water leaks, river rush, reflex ridge, soccer and football for the patients. | Other | Virtual reality training with motor imagery |
| Conventional physical therapyrange of motion exercises, muscle strengthening, functional training, balance training, and gait training. The specific tasks will be selected by the therapist based on the requirement of each patient. It will be performed for 30 minutes for 3 days a week for 6 weeks | Other | Conventional physical therapy |
Primary outcome
Dynamic Gait Index DGI
Time frame: 6th week
Clinical tool to assess gait, balance and fall risk. It evaluates not only usual steady-state walking, but also walking during more challenging tasks
Berg Balance Scale BBS
Time frame: 6th week
Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
Fugl-Meyer Scale for lower extremity
Time frame: 6th week
This clinical tool is for assessment of lower limb function. It is a reliable and valid tool. Interrater and intrarater reliability coefficients are reported to be >0.85 for both upper and lower limb) the domain subscales and the entire scale.
Six Minute Walk Test
Time frame: 6th week
It is used to assess aerobic capacity and endurance.
1 secondary outcome
Barthel index
Time frame: 6th week
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 30 Jan 2024.
- Background: PubMed 28771379Lee HC, Huang CL, Ho SH, Sung WH. The Effect of a Virtual Reality Game Intervention on Balance for Patients with Stroke: A Randomized Controlled Trial. Games Health J. 2017 Oct;6(5):303-311. doi: 10.1089/g4h.2016.0109. Epub 2017 Aug 3.
- Background: PubMed 34111095Aslam M, Ain QU, Fayyaz P, Malik AN. Exer-gaming reduces fall risk and improves mobility after stroke. J Pak Med Assoc. 2021 Jun;71(6):1673-1675. doi: 10.47391/JPMA.875.
- Background: PubMed 25206611Bao X, Mao Y, Lin Q, Qiu Y, Chen S, Li L, Cates RS, Zhou S, Huang D. Mechanism of Kinect-based virtual reality training for motor functional recovery of upper limbs after subacute stroke. Neural Regen Res. 2013 Nov 5;8(31):2904-13. doi: 10.3969/j.issn.1673-5374.2013.31.003.
- Background: PubMed 32970328Silva S, Borges LR, Santiago L, Lucena L, Lindquist AR, Ribeiro T. Motor imagery for gait rehabilitation after stroke. Cochrane Database Syst Rev. 2020 Sep 24;9(9):CD013019. doi: 10.1002/14651858.CD013019.pub2.
- Background: PubMed 32332810Bovonsunthonchai S, Aung N, Hiengkaew V, Tretriluxana J. A randomized controlled trial of motor imagery combined with structured progressive circuit class therapy on gait in stroke survivors. Sci Rep. 2020 Apr 24;10(1):6945. doi: 10.1038/s41598-020-63914-8.
- Background: PubMed 32212254Lin RC, Chiang SL, Heitkemper MM, Weng SM, Lin CF, Yang FC, Lin CH. Effectiveness of Early Rehabilitation Combined With Virtual Reality Training on Muscle Strength, Mood State, and Functional Status in Patients With Acute Stroke: A Randomized Controlled Trial. Worldviews Evid Based Nurs. 2020 Apr;17(2):158-167. doi: 10.1111/wvn.12429. Epub 2020 Mar 25.
- Background: PubMed 29529919Askin A, Atar E, Kocyigit H, Tosun A. Effects of Kinect-based virtual reality game training on upper extremity motor recovery in chronic stroke. Somatosens Mot Res. 2018 Mar;35(1):25-32. doi: 10.1080/08990220.2018.1444599. Epub 2018 Mar 13.
- Background: PubMed 28955088Malik AN, Masood T. Effects of virtual reality training on mobility and physical function in stroke. J Pak Med Assoc. 2017 Oct;67(10):1618-1620.
- Background: PubMed 28824816Chanpimol S, Seamon B, Hernandez H, Harris-Love M, Blackman MR. Using Xbox kinect motion capture technology to improve clinical rehabilitation outcomes for balance and cardiovascular health in an individual with chronic TBI. Arch Physiother. 2017;7:6. doi: 10.1186/s40945-017-0033-9. Epub 2017 May 31.
- Background: PubMed 27791207In T, Lee K, Song C. Virtual Reality Reflection Therapy Improves Balance and Gait in Patients with Chronic Stroke: Randomized Controlled Trials. Med Sci Monit. 2016 Oct 28;22:4046-4053. doi: 10.12659/msm.898157.
- Background: PubMed 27446778Im H, Ku J, Kim HJ, Kang YJ. Virtual Reality-Guided Motor Imagery Increases Corticomotor Excitability in Healthy Volunteers and Stroke Patients. Ann Rehabil Med. 2016 Jun;40(3):420-31. doi: 10.5535/arm.2016.40.3.420. Epub 2016 Jun 29.
- Background: PubMed 27237336Gibbons EM, Thomson AN, de Noronha M, Joseph S. Are virtual reality technologies effective in improving lower limb outcomes for patients following stroke - a systematic review with meta-analysis. Top Stroke Rehabil. 2016 Dec;23(6):440-457. doi: 10.1080/10749357.2016.1183349. Epub 2016 May 30.
- 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.
Binash Afzal, PHD* principal investigator
Riphah international university lahore campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality training with motor imagery and Conventional physical therapy in people with Stroke, 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 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 30 Jan 2024. 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?
Dynamic Gait Index DGI (time frame: 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 NCT05411653, which also lists 14 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 30 Jan 2024.