Effects of Training in a Virtual Environment in Chronic Stroke Patients
1 november 2018 uppdaterad av: University of Sao Paulo General Hospital
Effects of Training in a Virtual Environment on the Motor Function,Postural Control and Quality of Life in Chronic Stroke Patients: A Randomized Controlled Trial
The objective of this work will be compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the (1) motor function, (2) cognition, (3) balance and (4) gait in chronic stroke patients.
It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.
Forty patients will be randomly assigned in control and experimental group, 20 each one.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The objective of this work is to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, motor function, balance and quality of life in chronic stroke patients.
It is a prospective, single-blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.
Forty chronic stroke patients are randomly in control and experimental group, 20 each one.
Both groups conduct 14 training sessions, twice a week, for seven weeks.
Each session will consist a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises.
After this, both groups will performed more 30 minutes of balance training: the control group will performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group will performed the balance training with 8 Wii Fit games which stimulate motor and cognitive functions.
The main outcome measures will be: (1) the lower limb subscale of the Fugl-Meyer Assessment (FMA-LE); (2); Balance Evaluation Systems Test (BESTest);(3) the Stroke-Specific Quality of Life (SS-QOL); (4) 6- minute walk test (6MWT) and (5) The limits of stability (LOS).
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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São Paulo, Brasilien, 05360-160
- Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- hemiparetic status resulting from a single stroke at least 6 months earlier;
- the ability to walk 10 m independently with or without an assistive device;
- the absence of a musculoskeletal condition that could potentially affect the ability to walk safely;
- the absence of serious visual impairment or a hearing disorder;
- power of at least grade 3 in the hemiplegic lower extremity;
- able to understand and follow simple instructions.
Exclusion Criteria:
- a Montreal Cognitive Assessment (MoCA) score of < 20;
- severe dementia or aphasia;
- hemispatial neglect, ataxia or any other cerebellar symptom;
- inability to stand without minimal assist;
- Impaired vision
- Uncontrollable medical complications
- participation in other studies or rehabilitation programs
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Virtual Reality Training
The virtual reality training will be done by experimental group with ten games of Nintendo Wii Fit.
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The participants of the study will be trained 8 balance games during 14 sessions
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Aktiv komparator: Control group: Physical Therapy
The Control Group will be trained by conventional Physical Therapy exercises.
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Patients of the control group will be trained with balance exercises.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE)
Tidsram: up to 2 months
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FMA-LE is a subscale measuring lower limb motor recovery.
It examines movement and coordination of the hip, knee, and ankle in the supine, sitting, and standing positions.
Each item is scored on a 3-point scale (0, cannot perform; 1, partially performs; 2, performs fully).
The score range is 0 to 34, with higher scores indicating better lower limb motor performance
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up to 2 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Balance Evaluation Systems Test (BESTest)
Tidsram: Up 2 months
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Balance Evaluation Systems Test (BESTest) measures balance.
It includes 36 items that evaluate performance of 6 balance systems: biomechanical constraints, stability limits/verticality, anticipatory postural adjustments, postural responses, sensory orientation, and stability in gait.
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Up 2 months
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6-minute walk test
Tidsram: Up to 2 months
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The 6MWT is a practical simple test.
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD).
The 6MWT has been used as a measure of functional status of patients.
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Up to 2 months
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Stroke specific quality of life scale
Tidsram: Up to 2 months
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Stroke Specific Quality of Life Scale is a self-report assessment that includes 12 stroke specific subscales with 49 items.
The Stroke Specific Quality of Life Scale attempts to capture the domains of stroke specific QOL that are insufficiently assessed with generic QOL measures.
The 12 subscales, which are unidimensional, are Energy, Family Role, Language, Mobility, Mood, Personality, Self-Care, Social Roles, Thinking, Upper Extremity Function, Vision, and Work-Productivity.
Participants responded to each item on a 5-point scale.
Domain scores are the averages of the item scores, and the total score is the average of the domain scores.
All summary scores therefore range from 1 to 5. Higher scores indicate better function.
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Up to 2 months
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Limits of Stability
Tidsram: Up to 2 months
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The Limits of Stability subtest quantifies the maximum distance a person can intentionally displace their center of pressure (COP) from start position of midline COP centered over the base of support to eight targets.
Location and movement of the COP was indicated by a cursor display projected on a screen in front of the subject.
As targets were highlighted, the subject was to move the COP cursor quickly and accurately as possible towards a target located on the Limits of Stability perimeter and hold position as close to the target as possible.
The parameters include COP movement velocity and directional control (% to target).
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Up to 2 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Tatiana P Oliveira, PhD student, University of Sao Paulo
- Huvudutredare: Camila S Miranda, Ms Student, University of Sao Paulo
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 februari 2014
Primärt slutförande (Faktisk)
1 juni 2017
Avslutad studie (Faktisk)
1 februari 2018
Studieregistreringsdatum
Först inskickad
20 juni 2013
Först inskickad som uppfyllde QC-kriterierna
20 juni 2013
Första postat (Uppskatta)
25 juni 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 november 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 november 2018
Senast verifierad
1 juli 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- USPNEC005
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