StrokeNW-SPNCT04144556
Nintendo Wii® and Physical Therapy in Stroke Patients (NW-SP)
A study testing Nintendo Wii and conventional physical therapy and Conventional Physical therapy in people with Stroke, run by University of Valencia at 1 site in Spain.
Trial summary
Brief Summary: In the present study a program which combines virtual rehabilitation through Nintendo Wii and conventional physical therapy is applied in stroke patients, evaluating functional capability (TUG), gait and balance (POMA and BBS), motor impairment (FMA), daily living activities (Barthel) and complex… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Nintendo Wii and conventional physical therapy and Conventional Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 2 Nov 2019to 30 Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women aged 18 to 80 years
- having had a first simple stroke (ischemic or hemorrhagic) in one cerebral hemisphere
- onset of stroke at least 6 months prior to study inclusion
- have physical limitation in the upper limb and/or lower limb function.
Who cannot join
- have other morbid neurological conditions
- have hand anesthesia
- show severe cognitive impairment that prevents speaking or understanding both questions and simple instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Nintendo Wii® and Conventional Physical Therapy in Functional Capability and Daily Living Activities in Stroke Patients.
Brief Summary: In the present study a program which combines virtual rehabilitation through Nintendo Wii and conventional physical therapy is applied in stroke patients, evaluating functional capability (TUG), gait and balance (POMA and BBS), motor impairment (FMA), daily living activities (Barthel) and complex activities (FAI).
The hypothesis is that a virtual rehabilitation, through the use of Nintendo Wii®, could be used to improve functionality, gait, balance and living activities of people with chronic physical disabilities in addition to a conventional physical intervention program.
Methods: randomized and controlled clinical study of functional and motor parameters of stroke patients. The subjects will be divided into 2 groups: 1) Nintendo Wii and conventional physical therapy 2) control group which will have conventional physical therapy applied. There will be 2 treatment sessions during 4 weeks, with evaluations before the study and after 4 weeks, which include: functional capability (Timed up and go test), gait and balance performance (Tinetti performance-oriented mobility assessment and Berg balance scale), motor impairment (Fugl-Meyer assessment), daily living activities (Barthel Index) and complex activities (Frenchay activity index).
Read the detailed description
Introduction. Stroke is one of the most common causes of acquired adult disability. Much of the focus of stroke rehabilitation, in particular, the work of physiotherapists, is focused on recovery of physical independence and functional ability during activities of daily living. Physiotherapy based on conventional therapy has been shown to produce good results in recovery progress after stroke. However, patients tend to find the movements involved in this treatment as difficult and monotonous over time. Virtual rehabilitation is a novel therapeutic intervention based on simulation exercises using virtual reality technology.
Objective. The main objective of the present study was to assess whether a virtual rehabilitation program added to a conventional physical therapy intervention results in greater improvements in functional capability, gait, balance and daily activities compared to conventional physical therapy intervention on its own.
Material and Methods Sample: men and women aged 18 to 80 years having had a first simple stroke Study design. Randomized clinical trial with 2 groups: Group 1. 1) Nintendo Wii and conventional physical therapy 2) control group which will have conventional physical therapy applied.
Evaluations. Clinical interview with anthropometric data. There will be 2 evaluations: at the beginning of the study and at the end of the intervention (at 4 weeks).
In addition, it includes the following evaluation instruments:
- Functional capability: Timed up and go test (TUG)
- Gait and balance performance: Tinetti performance-oriented mobility assessment (POMA) and Berg balance scale (BBS)
- Motor impairment: Fugl-Meyer assessment (FMA)
- Daily living activities: Barthel Index.
- Complex activities: Frenchay activity index (FAI)
- Conditions
- Stroke
- Being tested
- Nintendo Wii and conventional physical therapy, Conventional Physical therapy
- Keywords
- Stroke, virtual reality, physical therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo Wii and conventional physical therapyOther
This group of patients will receive, in addition to the exercise program described below, a virtual rehabilitation program through Nintendo Wii. This program will include upper limb training and lower limb balance training. Participants will choose the games they want to perform the session with. "Wii Fit" (balance games) will be used for the treatment of the lower limbs, and "Wii Sports" (bowling, golf and tennis games) will be used for the treatment of the upper limbs.
Conventional Physical therapyOther
A warm-up period using a stationary bicycle, mobility exercises in supine position, active-assisted/passive kinesiotherapy of the lower and upper limbs, strengthening exercises in sitting position, balance, stability and coordination exercises and walking re-education exercises.
| Study group | Role | What they receive |
|---|---|---|
| Nintendo Wii and conventional physical therapy | Experimental | This group of patients will receive, in addition to the exercise program described below, a virtual rehabilitation program through Nintendo Wii. This program will include upper limb training and lower limb balance training. Participants will choose the games they want to perform the session with. "Wii Fit" (balance games) will be used for the treatment of the lower limbs, and "Wii Sports" (bowling, golf and tennis games) will be used for the treatment of the upper limbs. Receives: Other: Nintendo Wii and conventional physical therapy |
| Conventional Physical therapy | Active comparator | A warm-up period using a stationary bicycle, mobility exercises in supine position, active-assisted/passive kinesiotherapy of the lower and upper limbs, strengthening exercises in sitting position, balance, stability and coordination exercises and walking re-education exercises. Receives: Other: Conventional Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capability: Timed up and go test (TUG)
The patient is timed from the moment he/she begins to get up from a chair, walks at a safe and comfortable pace to a line on the floor three meters away, turns and walks towards the chair until he or she sits down again. The subject wears his/her usual footwear and walking aids (cane or walker) if necessary. A faster time indicates better functional performance, indicating a time more than 20 seconds a reduced mobility and, in addition, a score of ≥ 13.5 seconds is used to identify an increased risk of falls.
Measured: 4 weeks
Gait and balance performance
The Tinetti Scale has been designed to evaluate the balance in different positions. It consists of sixteen situations divided into two blocks that require the active participation of the patient. One block assesses gait, in which the subject walks with the examiner first with his usual step, returning with a fast but safe step (using his usual walking aids) with a maximum possible score of 12 points; and the other block assesses balance (in seating, standing and transferring from one to another) with a maximum of 16 points being obtained. The maximum overall score between the two blocks is 28 points.
Measured: 4 weeks
The Berg Balance Scale (BBS)
The Berg Balance Scale (BBS) is a 14-item scale that quantitatively evaluates equilibrium (static and dynamic) and fall risk. The items are scored from 0 to 4; (0 = inability to complete the task; 4 = independent completion of the item). The maximum score is 56 points and the risk of falling limit is 45.
Measured: 4 weeks
Secondary outcomes (2)
Motor impairment: Fugl-Meyer assessment (FMA)
It consists of 33 tasks, divided into 4 parts (shoulder-forearm, wrist, hand, and coordination speed), which performance is used to assess quality of motion, reflex activity, and coordination. Each task is rated on a three-point scale (0 points = cannot perform; 2 points = totally accomplished). The higher the score, the less impairment the subject experiences (maximum score = 66 points).
Measured: 4 weeks
Daily living activities: Barthel Index.
It consists of ten items in which the respective disabilities in the proposed domains are valued from 0 to 10 or from 0 to 15 points. It contains 10 activities of daily living and its maximum score reaches 100 points.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start2 Nov 2019
- Primary completion15 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144556
- Sponsor's protocol ID
- ID0026
- Acronym
- NW-SP
- Status last verified
- Apr 2020
- First submitted
- 27 Oct 2019
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marques-Sule E, Arnal-Gomez A, Buitrago-Jimenez G, Suso-Marti L, Cuenca-Martinez F, Espi-Lopez GV. Effectiveness of Nintendo Wii and Physical Therapy in Functionality, Balance, and Daily Activities in Chronic Stroke Patients. J Am Med Dir Assoc. 2021 May;22(5):1073-1080. doi: 10.1016/j.jamda.2021.01.076. Epub 2021 Feb 24.
PubMed 33639116
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nintendo Wii® and Conventional Physical Therapy in Functional Capability and Daily Living Activities in Stroke Patients.
- ClinicalTrials.gov ID
- NCT04144556
- Acronym / sponsor ID
- NW-SP / ID0026
- Conditions
- Stroke
- Keywords
- Stroke, virtual reality, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 2 Nov 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 30 Oct 2019 (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.
Brief Summary: In the present study a program which combines virtual rehabilitation through Nintendo Wii and conventional physical therapy is applied in stroke patients, evaluating functional capability (TUG), gait and balance (POMA and BBS), motor impairment (FMA), daily living activities (Barthel) and complex activities (FAI).
The hypothesis is that a virtual rehabilitation, through the use of Nintendo Wii®, could be used to improve functionality, gait, balance and living activities of people with chronic physical disabilities in addition to a conventional physical intervention program.
Methods: randomized and controlled clinical study of functional and motor parameters of stroke patients. The subjects will be divided into 2 groups: 1) Nintendo Wii and conventional physical therapy 2) control group which will have conventional physical therapy applied. There will be 2 treatment sessions during 4 weeks, with evaluations before the study and after 4 weeks, which include: functional capability (Timed up and go test), gait and balance performance (Tinetti performance-oriented mobility assessment and Berg balance scale), motor impairment (Fugl-Meyer assessment), daily living activities (Barthel Index) and complex activities (Frenchay activity index).
Detailed description
Introduction. Stroke is one of the most common causes of acquired adult disability. Much of the focus of stroke rehabilitation, in particular, the work of physiotherapists, is focused on recovery of physical independence and functional ability during activities of daily living. Physiotherapy based on conventional therapy has been shown to produce good results in recovery progress after stroke. However, patients tend to find the movements involved in this treatment as difficult and monotonous over time. Virtual rehabilitation is a novel therapeutic intervention based on simulation exercises using virtual reality technology.
Objective. The main objective of the present study was to assess whether a virtual rehabilitation program added to a conventional physical therapy intervention results in greater improvements in functional capability, gait, balance and daily activities compared to conventional physical therapy intervention on its own.
Material and Methods Sample: men and women aged 18 to 80 years having had a first simple stroke Study design. Randomized clinical trial with 2 groups: Group 1. 1) Nintendo Wii and conventional physical therapy 2) control group which will have conventional physical therapy applied.
Evaluations. Clinical interview with anthropometric data. There will be 2 evaluations: at the beginning of the study and at the end of the intervention (at 4 weeks).
In addition, it includes the following evaluation instruments:
- Functional capability: Timed up and go test (TUG)
- Gait and balance performance: Tinetti performance-oriented mobility assessment (POMA) and Berg balance scale (BBS)
- Motor impairment: Fugl-Meyer assessment (FMA)
- Daily living activities: Barthel Index.
- Complex activities: Frenchay activity index (FAI)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintendo Wii and conventional physical therapy | Experimental | Other: Nintendo Wii and conventional physical therapyThis group of patients will receive, in addition to the exercise program described below, a virtual rehabilitation program through Nintendo Wii. This program will include upper limb training and lower limb balance training. Participants will choose the games they want to perform the session with. "Wii Fit" (balance games) will be used for the treatment of the lower limbs, and "Wii Sports" (bowling, golf and tennis games) will be used for the treatment of the upper limbs. |
| Conventional Physical therapy | Active comparator | Other: Conventional Physical therapyA warm-up period using a stationary bicycle, mobility exercises in supine position, active-assisted/passive kinesiotherapy of the lower and upper limbs, strengthening exercises in sitting position, balance, stability and coordination exercises and walking re-education exercises. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men and women aged 18 to 80 years
- having had a first simple stroke (ischemic or hemorrhagic) in one cerebral hemisphere
- onset of stroke at least 6 months prior to study inclusion
- have physical limitation in the upper limb and/or lower limb function.
Key exclusion criteria (3 listed)
- have other morbid neurological conditions
- have hand anesthesia
- show severe cognitive impairment that prevents speaking or understanding both questions and simple instructions.
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 |
|---|---|---|
| Nintendo Wii and conventional physical therapyThis group of patients will receive, in addition to the exercise program described below, a virtual rehabilitation program through Nintendo Wii. This program will include upper limb training and lower limb balance training. Participants will choose the games they want to perform the session with. "Wii Fit" (balance games) will be used for the treatment of the lower limbs, and "Wii Sports" (bowling, golf and tennis games) will be used for the treatment of the upper limbs. | Other | Nintendo Wii and conventional physical therapy |
| Conventional Physical therapyA warm-up period using a stationary bicycle, mobility exercises in supine position, active-assisted/passive kinesiotherapy of the lower and upper limbs, strengthening exercises in sitting position, balance, stability and coordination exercises and walking re-education exercises. | Other | Conventional Physical therapy |
Primary outcome
Functional capability: Timed up and go test (TUG)
Time frame: 4 weeks
The patient is timed from the moment he/she begins to get up from a chair, walks at a safe and comfortable pace to a line on the floor three meters away, turns and walks towards the chair until he or she sits down again. The subject wears his/her usual footwear and walking aids (cane or walker) if necessary. A faster time indicates better functional performance, indicating a time more than 20 seconds a reduced mobility and, in addition, a score of ≥ 13.5 seconds is used to identify an increased risk of falls.
Gait and balance performance
Time frame: 4 weeks
The Tinetti Scale has been designed to evaluate the balance in different positions. It consists of sixteen situations divided into two blocks that require the active participation of the patient. One block assesses gait, in which the subject walks with the examiner first with his usual step, returning with a fast but safe step (using his usual walking aids) with a maximum possible score of 12 points; and the other block assesses balance (in seating, standing and transferring from one to another) with a maximum of 16 points being obtained. The maximum overall score between the two blocks is 28 points.
The Berg Balance Scale (BBS)
Time frame: 4 weeks
The Berg Balance Scale (BBS) is a 14-item scale that quantitatively evaluates equilibrium (static and dynamic) and fall risk. The items are scored from 0 to 4; (0 = inability to complete the task; 4 = independent completion of the item). The maximum score is 56 points and the risk of falling limit is 45.
2 secondary outcomes
Motor impairment: Fugl-Meyer assessment (FMA)
Time frame: 4 weeks
Daily living activities: Barthel Index.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Derived from this study: PubMed 33639116Marques-Sule E, Arnal-Gomez A, Buitrago-Jimenez G, Suso-Marti L, Cuenca-Martinez F, Espi-Lopez GV. Effectiveness of Nintendo Wii and Physical Therapy in Functionality, Balance, and Daily Activities in Chronic Stroke Patients. J Am Med Dir Assoc. 2021 May;22(5):1073-1080. doi: 10.1016/j.jamda.2021.01.076. Epub 2021 Feb 24.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nintendo Wii and conventional physical therapy and Conventional Physical therapy in people with Stroke, run by University of Valencia at 1 site in Spain.
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 3 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 3 Apr 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 Spain. 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?
Functional capability: Timed up and go test (TUG) (time frame: 4 weeks). The study lists 3 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 NCT04144556, which also lists 1 linked publication.
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 3 Apr 2020.