Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000473066
Ethics application status
Approved
Date submitted
2/06/2010
Date registered
10/06/2010
Date last updated
10/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development and evaluation of a functional rehabilitation system for upper extremity function in stroke patients.
Scientific title
Effects of physiotherapy, Electromyography (EMG) feedback and EMG-Controlled Exoskeletal on Upper Limb Recovery after Stroke.
Secondary ID [1] 251931 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor upper extremity function in stroke patients 257505 0
Condition category
Condition code
Stroke 257663 257663 0 0
Ischaemic
Stroke 257664 257664 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Participants of the training groups participated in individual 3 times per week, for 50 minutes sessions of EMG feedback upper muscle training and others participants participated of EMG-controlled exoskeletal upper limb powered orthosis for exercise training supervise by one physiotherapist with the same background during 2 months.
EMG Feedback: The participants realized series of flexion/ extension movements of the elbow, wrist and fingers joints. During the accomplishment of these exercises, the participants seated in front of the computer and will have visual aid of one feedback indicating how much of muscular contraction it must be produced for the accomplishment of each movement.
EMG-Controlled Exoskeletal training: During the sessions the particpants realized series of functional upper limbs tasks , such as, to move blocks, boxes and other utensils etc. There is a active-assisted therapy. During active-assisted training, the Exoskeletal provided assistance (by EMG activity trigger) in functional task if the subject was unable to reach it independently.
Intervention code [1] 256599 0
Rehabilitation
Comparator / control treatment
The Participants of the control group participated in individual weekly 50 minutes sessions of conventional physiotherapy, that involves strength, stretching and functional training exercises during 2 months. The treatment can vary as individual necessities.
Control group
Active

Outcomes
Primary outcome [1] 258570 0
Evaluate the efficiency of the EMG feedback and EMG-controlled exoskeletal orthosis training on upper limb motor rehabilitation by Fulg-Meyer Scale.
Timepoint [1] 258570 0
baseline and 2 months postintervention
Secondary outcome [1] 264433 0
Evaluate the efficiency of the EMG feedback and EMG-controlled exoskeletal orthosis training on upper limb functional rehabilitaton by Upper extremity performance test for the elderly (TEMPA).
Timepoint [1] 264433 0
baseline and 2 months postintervention

Eligibility
Key inclusion criteria
Hemiparesis resulting from a single ischemic or hemorrhagic stroke event, spasticity classified between levels 0 and 2 on the Modified Ashworth Scale of Muscle Spasticity for the upper limb affected and minimum sequela time of 6 months.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
clinical signs of cardiac alterations, arrhythmia or angina; absence of other neurological impairment and capacity to obey simple verbal commands.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment outside Australia
Country [1] 2677 0
Brazil
State/province [1] 2677 0

Funding & Sponsors
Funding source category [1] 257094 0
Government body
Name [1] 257094 0
National Council for Scientific and Technological Development (CNPq)
Country [1] 257094 0
Brazil
Primary sponsor type
University
Name
Universidade Federal de Minas Gerais
Address
Av. Antonio Carlos, 6627
Pampulha
31270-901 - Belo Horizonte, MG - Brasil
Country
Brazil
Secondary sponsor category [1] 256351 0
University
Name [1] 256351 0
Universidade de Pernambuco
Address [1] 256351 0
BR 203 Km 2 S/N
Vila Eduardo
56300-000 - Petrolina, PE - Brasil
Country [1] 256351 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259128 0
Ethics Committee of the University of Pernambuco
Ethics committee address [1] 259128 0
Av. Agamenon Magalhaes S/N, Santo Amaro, Recife, PE
CEP 50.100-010
Ethics committee country [1] 259128 0
Brazil
Date submitted for ethics approval [1] 259128 0
Approval date [1] 259128 0
20/11/2009
Ethics approval number [1] 259128 0
201/2009

Summary
Brief summary
This study will compared the effects of 3 differents rehabilitation programs for stroke patients with upper limbs functional disabilities. Participants will take part in a 2 months supervised rehabilitation program 3 times per week, for 1 hour. We hypothesized that stroke survivors with persistent weakness after stroke would be able to safely and effectively control the EMG exoskeletal orthosis, allowing them to perform exercise training with the device.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31250 0
Address 31250 0
Country 31250 0
Phone 31250 0
Fax 31250 0
Email 31250 0
Contact person for public queries
Name 14497 0
Rodrigo Cappato de Araujo
Address 14497 0
BR 203 Km 2 S/N
Vila Eduardo
56300-000 - Petrolina, PE - Brasil
Country 14497 0
Brazil
Phone 14497 0
55 87 38614515
Fax 14497 0
Email 14497 0
rodrigocappato@upe.br
Contact person for scientific queries
Name 5425 0
Marcos Pinotti
Address 5425 0
Av. Antonio Carlos, 6627
Pampulha
31270-901 - Belo Horizonte, MG - Brasil
Country 5425 0
Brazil
Phone 5425 0
55 31 34995242
Fax 5425 0
Email 5425 0
pinotti@ufmg.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.