Virtual Rehabilitation and Conventional Therapeutic Exercises in the Treatment of Individuals Post Stroke

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Virtual Rehabilitation

Conventional therapeutic exercises

Virtual Rehabilitation and Conventional Therapeutic Exercise

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Hemiparesis, Physical Therapy, Virtual Reality Exposure Therapy, Video Games

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Complex Hospital Professor Edgard Santos, Federal University of Bahia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Virtual Rehabilitation - VR

Conventional Therapeutic Exercises - CTE

VR and CTE

Arm Description

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).

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;

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02715817

First Posted

March 17, 2016

Last Updated

December 10, 2017

Sponsor

Federal University of Bahia

1. Study Identification

Unique Protocol Identification Number

NCT02715817

Brief Title

Virtual Rehabilitation and Conventional Therapeutic Exercises in the Treatment of Individuals Post Stroke

Official Title

The Effect of Virtual Rehabilitation With Nintendo Wii ® and Conventional Therapeutic Exercises in the Treatment of Individuals Post Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Bahia

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Cerebrovascular Disorders

Keywords

Stroke, Hemiparesis, Physical Therapy, Virtual Reality Exposure Therapy, Video Games

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Virtual Rehabilitation - VR

Arm Type

Active Comparator

Arm Description

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).

Arm Title

Conventional Therapeutic Exercises - CTE

Arm Type

Active Comparator

Arm Description

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;

Arm Title

VR and CTE

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Virtual Rehabilitation

Other Intervention Name(s)

NW, Non-immersive virtual reality, Commercial Game, Wii-rehabilitation

Intervention Description

It is the use of the NW games for rehabilitation of balance and gaite in post-stroke patients.

Intervention Type

Other

Intervention Name(s)

Conventional therapeutic exercises

Other Intervention Name(s)

Conventional physical therapy, Conventional exercises to improve balance and gait, Diagonals of PNF, PNF method

Intervention Description

It is the use of the conventional therapeutic exercises for rehabilitation of balance and gait in post-stroke patients.

Intervention Type

Other

Intervention Name(s)

Virtual Rehabilitation and Conventional Therapeutic Exercise

Other Intervention Name(s)

Non-immersive virtual reality, Wii-rehabilitation, Commercial Game, Conventional exercises to improve balance and gait, Diagonals of PNF

Intervention Description

It is the use of the conventional exercises and of the NW for rehabilitation of balance and gait in post-stroke patients.

Primary Outcome Measure Information:

Title

BBS

Description

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.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

TGS

Description

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.

Time Frame

8 weeks

Title

QLSSS

Description

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.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ailton S Melo, PhD

Organizational Affiliation

Federal University of Bahia

Official's Role

Study Director

Facility Information:

Facility Name

Complex Hospital Professor Edgard Santos, Federal University of Bahia

City

Salvador

State/Province

Bahia

ZIP/Postal Code

40.110-060

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

26258455

Citation

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.

Results Reference

background

PubMed Identifier

20508185

Citation

Saposnik 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.

Results Reference

background

PubMed Identifier

20088994

Citation

Saposnik 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.

Results Reference

background

PubMed Identifier

26303792

Citation

Dos 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.

Results Reference

background

PubMed Identifier

26834335

Citation

Kim 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.

Results Reference

background

PubMed Identifier

26157240

Citation

Seo 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.

Results Reference

background

Links:

URL

http://www.who.int/topics/cerebrovascular_accident/en/

Description

World Health Organization. Health topics: Stroke, Cerebrovascular accident.

URL

http://www.ebrsr.com/

Description

Evidence-Based Review of Stroke Rehabilitation (EBRSR)

Stroke, Cerebrovascular Disorders

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial