StrokeNCT04669431
Xbox Kinect Training on Upper Limb Motor Function in Stroke Patients
A study testing Xbox kinect Training and Conservative Rehabilitation in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
.To determine the effects of Xbox Kinect training on upper limb motor function with conventional physical therapy in stroke patients Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Xbox kinect Training and Conservative Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Jun 2018to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke>6 months
- No prior stroke
- Modified Ashworth scale<4
- Patients able to follow instructions
Who cannot join
- No previous deformity
- Severe spastic hemiplegic
- Patients with visual and cognitive impairment
- Patients suffering from arm pain
- Severe illness
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Railway General Hospital
Rawalpindi, Punjab Province, 44000
About this study
Official title: Effect Of Xbox Kinect Training on Upper Limb Motor Function in Stroke Patients
.To determine the effects of Xbox Kinect training on upper limb motor function with conventional physical therapy in stroke patients
Read the detailed description
Physical therapy is the best adopted cure strategy in all over the world towards "excellence of life in post stroke patients." Physical therapy can be well-defined as "the health approach whose purpose is to make people able with good health conditions, undergoing or prone to undergo disability for the attainment and maintenance of optimum functioning in collaboration with the surroundings. The main objective of stroke physical therapy is to reduce disability and make people as healthy as to perform their daily life activities independently, do not relay on others and integrate into social life up to their own desires and expectations.
Significant reduction in impairments of upper limbs in stroke patient was noticed after goal oriented computer gaming. Motor function of upper limb has shown significant results after mirror therapy in comparison to conservative treatment.
Among new approaches used for rehabilitation, Robotic assisted therapy is also included. After neurological injury, the current technological advances ensure to the improvement of robotic devices to offer harmless and intensive recovery to the person with mild to moderate motor impairments. Robotic devices in physical therapy, offer more power, repeated, and task based interactive treatment session for impaired motor function of upper limb by providing patient's progress. So it's considered as the reliable source of rehabilitation. Rather like physical therapy exercises robotic devices can also be used to affect arm by high power and task specific movement. Repetitive movements are guided through a stereotyped procedure. If the movements are facilitated by external forces applied to the limb, highly repetitive stereotyped movements can be effective in stroke subjects.
A comparatively novel tool evolving in the field of physical rehabilitation is virtual reality based rehabilitation. Virtual reality (VR) can be well defined as an non natural and artificial computer generated reproduction or creation of a real life environment or condition permitting the user to navigate through interact with.
Virtual reality consists of computer hardware and software, provides a sort of interactive simulation to users which are almost near to real environment. Subjects participate in VR environment with pronounced motivation and enjoyable manner due to realistic visual sensory perception and thus simulates body movements of daily life.
There are two main types of VR. Non-immersive virtual reality and immersive virtual reality. In non-immersive environment user feels both the real and virtual environment. While in immersive, real world perception of subjects is being blocked and only virtual images are being seen.
The use of VR in physical rehabilitation programs can offer several benefits. First, environments and situations that are excessively dangerous, costly or impossible in real life can be computer-generated with the use of VR.
Second, these virtual environments (VEs) are fully controllable by therapists and researchers, giving the chance to bring real environments or situations.
Third, VE are artificially made and can therefore easily be changed, constructing the possibility to design modified environments and therapies.
Fourth, VR has the potential to increase patient 's enthusiasm by creating more exciting training environments causing in more repetitions and longer training duration, eventually improving patients' treatment compliance. VR interventions are advantageous for motor rehabilitation of the stroke survivors.
VR systems enhance movement intensity which is compulsory for the induction of neuronal plasticity. VR actually provides immediate feedback which allows users to interact with full attention and patient does so because he was determined to attain maximum scores. VR works upon the cortical reorganisation which is also facilitated by sensory visual and auditory feedback.There is an enormous literature supports for the use of Virtual reality based rehabilitation as compared with conventional therapies
- Conditions
- Stroke
- Being tested
- Xbox kinect Training, Conservative Rehabilitation
- Keywords
- Xbox Kinect Training, Upper limb, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xbox kinect TrainingOther
Xbox kinect 360, Tennis player, Joy riding, Rally ball. Tennis player in first 2 weeks, Joy riding in 3rd and 4th weeks, and all 3 games in 5th and 6th weeks 35 minute/3 days a week for 6 weeks with Conventional physical therapy, 25 minute
Conservative RehabilitationOther
Sustained Stretching, repetitive task training, activities of daily living( eating, grooming, folding of towel, basket lifting, turn key into lock, reaching forward, sideways reach, ball grasping, picking up small blocks and lifting cane and pencil) 35 minute/3 days a week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Xbox kinect Training | Experimental | X Box Games include Tennis Playing, Joy riding, Rally ball. Receives: Other: Xbox kinect Training |
| Conservative Rehabilitation | Active comparator | Sustained Stretching, repetitive task training, activities of daily living Receives: Other: Conservative Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
Changes from the base line, Primary tools for measuring spasticity in post stroke patients, is Modified Ashworth Scale.
Modified Ashworth Scale (MAS) is a measuring tool for spasticity consisting on total of 6 points. Marks ranges from zero to four, where 0 indicates normal muscle tone while higher numbers signifies high resistance.
Measured: 6th week
Montreal Cognitive Assessment
Changes from the base line, The tool used for cognitive impairment is Montreal Cognitive Assessment (MoCA). As there is not at all, fairly effective measuring tool for the early diagnosis of cognitive impairments. MoCA is a successful screening test used for the screening of mild cognitive impairment. The MoCA test-retest intra-class relationship coefficient (ICC=0.79) and the inter-rater intra-class connection coefficient (ICC=0.81).The MoCA is a valid and reliable tool for cognitive assessment. Scores of MoCA ranges from 0-30.Interpretation of MoCA indicates that score of 26 and above normal, 18 -25 score indicates low cognitive impairments, 10 -18 score considered normal or moderate cognitive impairment while greater than 10 is considered to be severe cognitive impairments.
Measured: 6th week
Test Box and Block
Changes from the Baseline, Test Box and block (BBT) measuring tool is used for the motor function of upper extremity.
In the apparatus of this tool, there are two compartments of a box, and test is performed by picking up equal sized blocks from one compartment to another during 60 seconds. 15 seconds are provided to subjects for practice and then total numbers of blocks, transferred within 60 seconds are recorded.
Measured: 6th week
Wolf Motor Function Test
Changes from the Baseline, Wolf Motor Function Test (WMFT) is considered as numerical catalogue for the assessment of upper extremity motor function. Motor skills of patients are assessed through time and well designed, practical and functional tasks.
Measured: 6th week
Fugl Meyer assessment of physical performance
Changes from the Baseline, Fugl meyer assessment tool is used for the evaluation of recovery extent in post stroke patients. It consists of 226 total points and is divided in 5 major domains including sensory function, motor function, joint range of motion, balance and pain each domain contain multiple sub items. Scoring is being recorded on a 3-points ordinal scale where zero means unable to perform, one means partially performs and two means performs fully. Movement, coordination, reflex activity of shoulders, elbows, forearm, wrist and hand are included in motor domain. Normal motor performance starts from 0 to maximum 100 points and sub divided into 66 points for upper extremity.
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 posted16 Dec 2020
- Study start18 Jun 2018
- Primary completion1 Feb 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amna Yaseen, MSPT(NMPT), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669431
- Sponsor's protocol ID
- REC/00514 Sara khan
- Status last verified
- Dec 2020
- First submitted
- 9 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Xbox Kinect Training on Upper Limb Motor Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT04669431
- Acronym / sponsor ID
- REC/00514 Sara khan
- Conditions
- Stroke
- Keywords
- Xbox Kinect Training, Upper limb, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 16 Dec 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.
.To determine the effects of Xbox Kinect training on upper limb motor function with conventional physical therapy in stroke patients
Detailed description
Physical therapy is the best adopted cure strategy in all over the world towards "excellence of life in post stroke patients." Physical therapy can be well-defined as "the health approach whose purpose is to make people able with good health conditions, undergoing or prone to undergo disability for the attainment and maintenance of optimum functioning in collaboration with the surroundings. The main objective of stroke physical therapy is to reduce disability and make people as healthy as to perform their daily life activities independently, do not relay on others and integrate into social life up to their own desires and expectations.
Significant reduction in impairments of upper limbs in stroke patient was noticed after goal oriented computer gaming. Motor function of upper limb has shown significant results after mirror therapy in comparison to conservative treatment.
Among new approaches used for rehabilitation, Robotic assisted therapy is also included. After neurological injury, the current technological advances ensure to the improvement of robotic devices to offer harmless and intensive recovery to the person with mild to moderate motor impairments. Robotic devices in physical therapy, offer more power, repeated, and task based interactive treatment session for impaired motor function of upper limb by providing patient's progress. So it's considered as the reliable source of rehabilitation. Rather like physical therapy exercises robotic devices can also be used to affect arm by high power and task specific movement. Repetitive movements are guided through a stereotyped procedure. If the movements are facilitated by external forces applied to the limb, highly repetitive stereotyped movements can be effective in stroke subjects.
A comparatively novel tool evolving in the field of physical rehabilitation is virtual reality based rehabilitation. Virtual reality (VR) can be well defined as an non natural and artificial computer generated reproduction or creation of a real life environment or condition permitting the user to navigate through interact with.
Virtual reality consists of computer hardware and software, provides a sort of interactive simulation to users which are almost near to real environment. Subjects participate in VR environment with pronounced motivation and enjoyable manner due to realistic visual sensory perception and thus simulates body movements of daily life.
There are two main types of VR. Non-immersive virtual reality and immersive virtual reality. In non-immersive environment user feels both the real and virtual environment. While in immersive, real world perception of subjects is being blocked and only virtual images are being seen.
The use of VR in physical rehabilitation programs can offer several benefits. First, environments and situations that are excessively dangerous, costly or impossible in real life can be computer-generated with the use of VR.
Second, these virtual environments (VEs) are fully controllable by therapists and researchers, giving the chance to bring real environments or situations.
Third, VE are artificially made and can therefore easily be changed, constructing the possibility to design modified environments and therapies.
Fourth, VR has the potential to increase patient 's enthusiasm by creating more exciting training environments causing in more repetitions and longer training duration, eventually improving patients' treatment compliance. VR interventions are advantageous for motor rehabilitation of the stroke survivors.
VR systems enhance movement intensity which is compulsory for the induction of neuronal plasticity. VR actually provides immediate feedback which allows users to interact with full attention and patient does so because he was determined to attain maximum scores. VR works upon the cortical reorganisation which is also facilitated by sensory visual and auditory feedback.There is an enormous literature supports for the use of Virtual reality based rehabilitation as compared with conventional therapies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xbox kinect Training | Experimental | Other: Xbox kinect TrainingX Box Games include Tennis Playing, Joy riding, Rally ball. |
| Conservative Rehabilitation | Active comparator | Other: Conservative RehabilitationSustained Stretching, repetitive task training, activities of daily living |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stroke>6 months
- No prior stroke
- Modified Ashworth scale<4
- Patients able to follow instructions
Key exclusion criteria (5 listed)
- No previous deformity
- Severe spastic hemiplegic
- Patients with visual and cognitive impairment
- Patients suffering from arm pain
- Severe illness
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 |
|---|---|---|
| Xbox kinect TrainingXbox kinect 360, Tennis player, Joy riding, Rally ball. Tennis player in first 2 weeks, Joy riding in 3rd and 4th weeks, and all 3 games in 5th and 6th weeks 35 minute/3 days a week for 6 weeks with Conventional physical therapy, 25 minute | Other | Xbox kinect Training |
| Conservative RehabilitationSustained Stretching, repetitive task training, activities of daily living( eating, grooming, folding of towel, basket lifting, turn key into lock, reaching forward, sideways reach, ball grasping, picking up small blocks and lifting cane and pencil) 35 minute/3 days a week for 6 weeks | Other | Conservative Rehabilitation |
Primary outcome
Modified Ashworth Scale
Time frame: 6th week
Changes from the base line, Primary tools for measuring spasticity in post stroke patients, is Modified Ashworth Scale. Modified Ashworth Scale (MAS) is a measuring tool for spasticity consisting on total of 6 points. Marks ranges from zero to four, where 0 indicates normal muscle tone while higher numbers signifies high resistance.
Montreal Cognitive Assessment
Time frame: 6th week
Changes from the base line, The tool used for cognitive impairment is Montreal Cognitive Assessment (MoCA). As there is not at all, fairly effective measuring tool for the early diagnosis of cognitive impairments. MoCA is a successful screening test used for the screening of mild cognitive impairment. The MoCA test-retest intra-class relationship coefficient (ICC=0.79) and the inter-rater intra-class connection coefficient (ICC=0.81).The MoCA is a valid and reliable tool for cognitive assessment. Scores of MoCA ranges from 0-30.Interpretation of MoCA indicates that score of 26 and above normal, 18 -25 score indicates low cognitive impairments, 10 -18 score considered normal or moderate cognitive impairment while greater than 10 is considered to be severe cognitive impairments.
Test Box and Block
Time frame: 6th week
Changes from the Baseline, Test Box and block (BBT) measuring tool is used for the motor function of upper extremity. In the apparatus of this tool, there are two compartments of a box, and test is performed by picking up equal sized blocks from one compartment to another during 60 seconds. 15 seconds are provided to subjects for practice and then total numbers of blocks, transferred within 60 seconds are recorded.
Wolf Motor Function Test
Time frame: 6th week
Changes from the Baseline, Wolf Motor Function Test (WMFT) is considered as numerical catalogue for the assessment of upper extremity motor function. Motor skills of patients are assessed through time and well designed, practical and functional tasks.
Fugl Meyer assessment of physical performance
Time frame: 6th week
Changes from the Baseline, Fugl meyer assessment tool is used for the evaluation of recovery extent in post stroke patients. It consists of 226 total points and is divided in 5 major domains including sensory function, motor function, joint range of motion, balance and pain each domain contain multiple sub items. Scoring is being recorded on a 3-points ordinal scale where zero means unable to perform, one means partially performs and two means performs fully. Movement, coordination, reflex activity of shoulders, elbows, forearm, wrist and hand are included in motor domain. Normal motor performance starts from 0 to maximum 100 points and sub divided into 66 points for upper extremity.
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 16 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Foot Drop Rehabilitation and Mobility in Chronic Stroke
Stroke
Enrolling by invitation
Study on the Efficacy and Safety of Non-Invasive Brain-Computer Interface With MRI-Guided Multi-Channel Time-Domain Interference Stimulation in Treating Motor Dysfunction in Acute Cerebral Infarction Patients
Acute Ichemic Stroke
RecruitingObservational study
Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
Stroke, Alzheimer s Disease
Enrolling by invitation
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Stroke, Spinal Cord Injuries (SCI)
Not yet recruitingPhase 2
Rimonabant for Improving Walking Ability in Patients With Chronic Stroke
Chronic 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.
Amna Yaseen, MSPT(NMPT) 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 Xbox kinect Training and Conservative Rehabilitation 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 4 inclusion and 5 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 16 Dec 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?
Modified Ashworth Scale (time frame: 6th week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.