Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000362998
Ethics application status
Approved
Date submitted
5/01/2011
Date registered
7/04/2011
Date last updated
7/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Analysis of the effects of motor imagery associated with kinesiotherapy upper limb of hemiparetic patients after stroke
Scientific title
Analysis of the effects of motor imagery associated with kinesiotherapy upper limb of hemiparetic patients after stroke
Secondary ID [1] 253387 0
the trial does not have a secondary ID
Universal Trial Number (UTN)
U1111-1118-8400
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
kinesiotherapy upper limb in hemiparetic storke 258887 0
Condition category
Condition code
Physical Medicine / Rehabilitation 259028 259028 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
the motor imagery is a rehabilitation technique that was applied one hour a day for two consecutive weeks. Assessments and reassessments were applied by an examiner and treatment were administered by another examiner. Individuals selected after evaluation were followed by a period of two consecutive weeks, Monday through Friday, with one hour each session, undergoing the use of motor imagery associated with exercise alone (based on activity of daily living (ADLs): sliced beef, sandwiches, eat with a spoon, drinking cup, comb his hair, opening a jar and come to pick up a small object). The activities were planned during all sessions. The procedure involved the following steps: STEP 1: The patient was filmed performing each activity of daily living every, STEP 2: Watch a video that was shown 10 times the correct way to perform each activity (pictures visual). STEP 3: with closed eyes held a series of 10 repetitions imagining the correct moves for each activity, without running them in fact, associated with the verbal command (kinesthetic images). STEP 4: held three sets of 10 repetitions of each activity. Walks through the steps all occurred the same day during 10 consecutive days
Intervention code [1] 257796 0
Rehabilitation
Comparator / control treatment
Compared before and after treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259879 0
The assessment of motor function through the Test of Motor ability Superior State (THMMS)- 30 score, Fugl Meyer Scale (FMS)- score 100 and Motor Activity Inventory (MAL)-score 30 and spasticity was assessed by the Modified Ashworth Scale (MAS)- score 5.
Results: After 10 sessions it was observed significant improvement in THMMS (p = 0.005) of the FMS (p = 0.005), MAL (p = 0.005) and elbow flexor muscle groups AMI (p = 0.014) and wrist flexors (p = 0.023)
Timepoint [1] 259879 0
Results: After 10 sessions it was observed significant improvement in THMMS (p = 0.005) of the FMS (p = 0.005), MAL (p = 0.005) and elbow flexor muscle groups AMI (p = 0.014) and wrist flexors (p = 0.023) and also saw significant improvement in time taken for completion of activities: cutting meat (p = 0.008) and sandwiches (p = 0.005), eating with a spoon (p = 0.005), drinking mug ( p = 0.011), combing hair (p = 0.018); open jar (p = 0.027) and extend the arm to pick up small object (p = 0.028)
Secondary outcome [1] 268972 0
none
Timepoint [1] 268972 0
none

Eligibility
Key inclusion criteria
The study included patients with ages ranging between 46 and 76 years, no distinction of race or gender and the individuals in question had good cognitive status which was assessed by the Mini-Mental State Examination (MMSE) and participants must present hemiparesis.
Minimum age
46 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The study excluded individuals with sequela of other diseases, who had a low cognitive level, under 18 and blind or deaf

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 3119 0
Brazil
State/province [1] 3119 0
Pouso Alegre

Funding & Sponsors
Funding source category [1] 258423 0
University
Name [1] 258423 0
University Vale to Sapucai
Country [1] 258423 0
Brazil
Primary sponsor type
Individual
Name
Adriana Teresa Silva
Address
Rua: Benjamin Constant 93
City: Alfenas
State: MG
CEP: 37130000
Country
Brazil
Secondary sponsor category [1] 257435 0
None
Name [1] 257435 0
Address [1] 257435 0
Country [1] 257435 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260402 0
1126/2009
Ethics committee address [1] 260402 0
Ethics committee country [1] 260402 0
Brazil
Date submitted for ethics approval [1] 260402 0
09/11/2009
Approval date [1] 260402 0
12/12/2009
Ethics approval number [1] 260402 0
1126/2009

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32053 0
Address 32053 0
Country 32053 0
Phone 32053 0
Fax 32053 0
Email 32053 0
Contact person for public queries
Name 15300 0
Adriana Teresa Silva
Address 15300 0
Rua: Benjamin Constant 93, centro, CEP: 37130-000 Alfenas-MG
Country 15300 0
Brazil
Phone 15300 0
553532911486
Fax 15300 0
Email 15300 0
[email protected]
Contact person for scientific queries
Name 6228 0
Adriana Teresa Silva
Address 6228 0
Rua: Benjamin Constant 93, bairro centro, CEP: 37130-000 Alfenas-MG
Country 6228 0
Brazil
Phone 6228 0
553532911486
Fax 6228 0
Email 6228 0
[email protected]

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.