StrokeNCT02715817
Virtual Rehabilitation and Conventional Therapeutic Exercises in the Treatment of Individuals Post Stroke
A study testing Virtual Rehabilitation, Conventional therapeutic exercises and Virtual Rehabilitation and Conventional Therapeutic Exercise in people with Stroke and Cerebrovascular Disorders, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
The purpose of this study is to determine the effects of the use the Nintendo Wii® (NW) and conventional therapeutic exercises in the rehabilitation of balance and gait of the post-stroke patients and the impact on quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Cerebrovascular Disorders
- What is being tested?
- Virtual Rehabilitation, Conventional therapeutic exercises and Virtual Rehabilitation and Conventional Therapeutic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Jun 2017
- 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
- age between 18 and 80 years, of both sexes; clinical diagnosis of stroke confirmed by neurological assessment report or neuroimaging;
- a stroke at least 6 months prior to the study
- the ability to walk independently with or without an assistive device;
- absence of visual or auditory deficits as reported by the subject.
Who cannot join
- score <24 on the Mini Mental State Examination;
- other associated neurological conditions;
- other orthopedic injuries that could impair mobility and make the execution of the proposed activity impossible;
- participation in other physical rehabilitation programs.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Complex Hospital Professor Edgard Santos, Federal University of Bahia
Salvador, Estado de Bahia, 40.110-060
About this study
Official title: The Effect of Virtual Rehabilitation With Nintendo Wii ® and Conventional Therapeutic Exercises in the Treatment of Individuals Post Stroke
The purpose of this study is to determine the effects of the use the Nintendo Wii® (NW) and conventional therapeutic exercises in the rehabilitation of balance and gait of the post-stroke patients and the impact on quality of life.
Read the detailed description
This Randomised clinical trial (RCT) has longitudinal and prospective feature, held at the Neurosciences Clinic located at the Clinic Professor Francisco Magalhães Neto the HUPES Complex / Federal University of Bahia from June 2015 until June 2017.
In the initial evaluation were obtained by a trained examiner and blinded to the allocation of participants, all personal data of all patients, as well as evaluations of balance, gait, and quality of life through specific validated scales:
- Berg Balance Scale (BBS);
- Tinetti Gait Scale (TGS)
- Quality of Life Scale Specific for stroke (QLSSS) ;
The investigators employ a program of conventional therapeutic exercises and virtual rehabilitation with NW, for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).
- Conditions
- Stroke, Cerebrovascular Disorders
- Being tested
- Virtual Rehabilitation, Conventional therapeutic exercises, Virtual Rehabilitation and Conventional Therapeutic Exercise
- Keywords
- Stroke, Hemiparesis, Physical Therapy, Virtual Reality Exposure Therapy, Video Games
- Medical subject headings
- Stroke, Cerebrovascular Disorders, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RehabilitationOther
Also called NW, Non-immersive virtual reality, Commercial Game, Wii-rehabilitation
It is the use of the NW games for rehabilitation of balance and gaite in post-stroke patients.
Conventional therapeutic exercisesOther
Also called Conventional physical therapy, Conventional exercises to improve balance and gait, Diagonals of PNF, PNF method
It is the use of the conventional therapeutic exercises for rehabilitation of balance and gait in post-stroke patients.
Virtual Rehabilitation and Conventional Therapeutic ExerciseOther
Also called Non-immersive virtual reality, Wii-rehabilitation, Commercial Game, Conventional exercises to improve balance and gait
It is the use of the conventional exercises and of the NW for rehabilitation of balance and gait in post-stroke patients.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Rehabilitation - VR | Active comparator | A virtual rehabilitation program (G0) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.
The G0 treatment program consists of the following protocols: a) protocol 1 games (Balance Bubble Plus and Tennis); b) protocol 2 games (Rhythm Parade and Boxing). Receives: Other: Virtual Rehabilitation |
| Conventional Therapeutic Exercises - CTE | Active comparator | A program of conventional therapeutic exercises (G1) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The G1 treatment program consists of the following protocols: a) protocol 1: 30 minutes of upper limb PNF diagonal exercise (flexion-abduction-external rotation and extension-abduction-internal rotation), and 10 minutes of scapula PNF diagonal exercise (anterior and posterior elevation); b) protocol 2: 20 minutes of lower limb PNF diagonal exercise (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes of pelvis PNF diagonal exercise (anterior and posterior depression), and 10 minutes gait cycle training; Receives: Other: Conventional therapeutic exercises |
| VR and CTE | Experimental | In G2 program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols. Receives: Other: Virtual Rehabilitation and Conventional Therapeutic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
BBS
It is a scale that allows a functional assessment of the balance of the performance. It is based on 14 common items of everyday life, graduated from 0 to 4 points, reaching 56 points maximum score.
Measured: 8 weeks
Secondary outcomes (2)
TGS
It is a 12-point instrument of observational analysis of gait ability. The count for each exercise ranges from 0 to 1 or from 0 to 2, with a lower score indicating a poorer physical ability.
Measured: 8 weeks
QLSSS
The QLSS was developed to measure the quality of life of patients with stroke sequela.It contains 49 items arranged into 12 fields, and the score for each item ranges from 1 to 5 points and the total score can range from 49 to 245, so that the lower the score, the greater the degree of dependence and difficult to perform tasks, which indicates a worse perception of quality of life.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luan Rafael Aguiar dos Santos, Federal University of Bahia
- Investigators
- Ailton S Melo, PhD, Study director, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715817
- Sponsor's protocol ID
- 943.738
- Status last verified
- Dec 2017
- First submitted
- 17 Mar 2016
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
da Silva Ribeiro NM, Ferraz DD, Pedreira E, Pinheiro I, da Silva Pinto AC, Neto MG, Dos Santos LR, Pozzato MG, Pinho RS, Masruha MR. Virtual rehabilitation via Nintendo Wii(R) and conventional physical therapy effectively treat post-stroke hemiparetic patients. Top Stroke Rehabil. 2015 Aug;22(4):299-305. doi: 10.1179/1074935714Z.0000000017. Epub 2015 Feb 25.
PubMed 26258455Saposnik G, Teasell R, Mamdani M, Hall J, McIlroy W, Cheung D, Thorpe KE, Cohen LG, Bayley M; Stroke Outcome Research Canada (SORCan) Working Group. Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle. Stroke. 2010 Jul;41(7):1477-84. doi: 10.1161/STROKEAHA.110.584979. Epub 2010 May 27.
PubMed 20508185Saposnik G, Mamdani M, Bayley M, Thorpe KE, Hall J, Cohen LG, Teasell R; EVREST Steering Committee; EVREST Study Group for the Stroke Outcome Research Canada Working Group. Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system. Int J Stroke. 2010 Feb;5(1):47-51. doi: 10.1111/j.1747-4949.2009.00404.x.
PubMed 20088994Dos Santos LR, Carregosa AA, Masruha MR, Dos Santos PA, Da Silveira Coelho ML, Ferraz DD, Da Silva Ribeiro NM. The Use of Nintendo Wii in the Rehabilitation of Poststroke Patients: A Systematic Review. J Stroke Cerebrovasc Dis. 2015 Oct;24(10):2298-305. doi: 10.1016/j.jstrokecerebrovasdis.2015.06.010. Epub 2015 Aug 21.
PubMed 26303792Kim K, Lee DK, Jung SI. Effect of coordination movement using the PNF pattern underwater on the balance and gait of stroke patients. J Phys Ther Sci. 2015 Dec;27(12):3699-701. doi: 10.1589/jpts.27.3699. Epub 2015 Dec 28.
PubMed 26834335Seo 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 26157240
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Rehabilitation With Nintendo Wii ® and Conventional Therapeutic Exercises in the Treatment of Individuals Post Stroke
- ClinicalTrials.gov ID
- NCT02715817
- Acronym / sponsor ID
- 943.738
- Conditions
- Stroke, Cerebrovascular Disorders
- Keywords
- Stroke, Hemiparesis, Physical Therapy, Virtual Reality Exposure Therapy, Video Games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 22 Mar 2016 (estimated)
- 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 purpose of this study is to determine the effects of the use the Nintendo Wii® (NW) and conventional therapeutic exercises in the rehabilitation of balance and gait of the post-stroke patients and the impact on quality of life.
Detailed description
This Randomised clinical trial (RCT) has longitudinal and prospective feature, held at the Neurosciences Clinic located at the Clinic Professor Francisco Magalhães Neto the HUPES Complex / Federal University of Bahia from June 2015 until June 2017.
In the initial evaluation were obtained by a trained examiner and blinded to the allocation of participants, all personal data of all patients, as well as evaluations of balance, gait, and quality of life through specific validated scales:
- Berg Balance Scale (BBS);
- Tinetti Gait Scale (TGS)
- Quality of Life Scale Specific for stroke (QLSSS) ;
The investigators employ a program of conventional therapeutic exercises and virtual rehabilitation with NW, for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Rehabilitation - VR | Active comparator | Other: Virtual RehabilitationA virtual rehabilitation program (G0) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The G0 treatment program consists of the following protocols: a) protocol 1 games (Balance Bubble Plus and Tennis); b) protocol 2 games (Rhythm Parade and Boxing). |
| Conventional Therapeutic Exercises - CTE | Active comparator | Other: Conventional therapeutic exercisesA program of conventional therapeutic exercises (G1) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The G1 treatment program consists of the following protocols: a) protocol 1: 30 minutes of upper limb PNF diagonal exercise (flexion-abduction-external rotation and extension-abduction-internal rotation), and 10 minutes of scapula PNF diagonal exercise (anterior and posterior elevation); b) protocol 2: 20 minutes of lower limb PNF diagonal exercise (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes of pelvis PNF diagonal exercise (anterior and posterior depression), and 10 minutes gait cycle training; |
| VR and CTE | Experimental | Other: Virtual Rehabilitation and Conventional Therapeutic ExerciseIn G2 program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 18 and 80 years, of both sexes; clinical diagnosis of stroke confirmed by neurological assessment report or neuroimaging;
- a stroke at least 6 months prior to the study
- the ability to walk independently with or without an assistive device;
- absence of visual or auditory deficits as reported by the subject.
Key exclusion criteria (4 listed)
- score <24 on the Mini Mental State Examination;
- other associated neurological conditions;
- other orthopedic injuries that could impair mobility and make the execution of the proposed activity impossible;
- participation in other physical rehabilitation programs.
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 RehabilitationAlso: NW, Non-immersive virtual reality, Commercial Game, Wii-rehabilitationIt is the use of the NW games for rehabilitation of balance and gaite in post-stroke patients. | Other | Virtual Rehabilitation - VR |
| Conventional therapeutic exercisesAlso: Conventional physical therapy, Conventional exercises to improve balance and gait, Diagonals of PNF, PNF methodIt is the use of the conventional therapeutic exercises for rehabilitation of balance and gait in post-stroke patients. | Other | Conventional Therapeutic Exercises - CTE |
| Virtual Rehabilitation and Conventional Therapeutic ExerciseAlso: Non-immersive virtual reality, Wii-rehabilitation, Commercial Game, Conventional exercises to improve balance and gaitIt is the use of the conventional exercises and of the NW for rehabilitation of balance and gait in post-stroke patients. | Other | VR and CTE |
Primary outcome
BBS
Time frame: 8 weeks
It is a scale that allows a functional assessment of the balance of the performance. It is based on 14 common items of everyday life, graduated from 0 to 4 points, reaching 56 points maximum score.
2 secondary outcomes
TGS
Time frame: 8 weeks
QLSSS
Time frame: 8 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 12 Dec 2017.
- Background: PubMed 26258455da Silva Ribeiro NM, Ferraz DD, Pedreira E, Pinheiro I, da Silva Pinto AC, Neto MG, Dos Santos LR, Pozzato MG, Pinho RS, Masruha MR. Virtual rehabilitation via Nintendo Wii(R) and conventional physical therapy effectively treat post-stroke hemiparetic patients. Top Stroke Rehabil. 2015 Aug;22(4):299-305. doi: 10.1179/1074935714Z.0000000017. Epub 2015 Feb 25.
- Background: PubMed 20508185Saposnik G, Teasell R, Mamdani M, Hall J, McIlroy W, Cheung D, Thorpe KE, Cohen LG, Bayley M; Stroke Outcome Research Canada (SORCan) Working Group. Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle. Stroke. 2010 Jul;41(7):1477-84. doi: 10.1161/STROKEAHA.110.584979. Epub 2010 May 27.
- Background: PubMed 20088994Saposnik G, Mamdani M, Bayley M, Thorpe KE, Hall J, Cohen LG, Teasell R; EVREST Steering Committee; EVREST Study Group for the Stroke Outcome Research Canada Working Group. Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system. Int J Stroke. 2010 Feb;5(1):47-51. doi: 10.1111/j.1747-4949.2009.00404.x.
- Background: PubMed 26303792Dos Santos LR, Carregosa AA, Masruha MR, Dos Santos PA, Da Silveira Coelho ML, Ferraz DD, Da Silva Ribeiro NM. The Use of Nintendo Wii in the Rehabilitation of Poststroke Patients: A Systematic Review. J Stroke Cerebrovasc Dis. 2015 Oct;24(10):2298-305. doi: 10.1016/j.jstrokecerebrovasdis.2015.06.010. Epub 2015 Aug 21.
- Background: PubMed 26834335Kim K, Lee DK, Jung SI. Effect of coordination movement using the PNF pattern underwater on the balance and gait of stroke patients. J Phys Ther Sci. 2015 Dec;27(12):3699-701. doi: 10.1589/jpts.27.3699. Epub 2015 Dec 28.
- 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.
- World Health Organization. Health topics: Stroke, Cerebrovascular accident.Link provided by the sponsor.
- Evidence-Based Review of Stroke Rehabilitation (EBRSR)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Ailton S Melo, PhD study director
Federal University of Bahia
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 Rehabilitation, Conventional therapeutic exercises and Virtual Rehabilitation and Conventional Therapeutic Exercise in people with Stroke and Cerebrovascular Disorders, run by Federal University of Bahia at 1 site in Brazil.
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 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 12 Dec 2017. 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 Brazil. 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?
BBS (time frame: 8 weeks). 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 NCT02715817, which also lists 6 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 12 Dec 2017.