Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000411943
Ethics application status
Approved
Date submitted
11/01/2011
Date registered
20/04/2011
Date last updated
20/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Biomechanical and Functional Improvement Post Constraint-Induced Movement Therapy and Forced Use Therapy in Rehabilitation of Patients With Chronic Hemiparesis Post-Stroke
Scientific title
Improvement after Constraint-Induced Movement Therapy versus Forced Use Therapy in Hemiparetics Post-Stroke: a randomized clinical trial
Secondary ID [1] 253348 0
SISNEP - CAAE 0119.0.004.000-06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 258885 0
hemiparesis 258886 0
Condition category
Condition code
Neurological 259025 259025 0 0
Other neurological disorders
Stroke 259026 259026 0 0
Ischaemic
Stroke 259027 259027 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both techinques, Constraint-Induced Moviment Therapy (CIMT) and Forced Use Therapy (FUT) use Immobilisation, mobilisation, and stretching of the non-paretic upper limb.
Immobilisation will be performed by means of a tubular mesh involving the non-paretic upper limb (UL) on abduction, rotating the shoulder internally, and allowing elbow flexion above 90 degrees. Immobilisation will be maintained for 24 hours during five days a week over a period of four weeks. The tubular mesh will be removed every day by the examiners for hygienisation, mobilisation, and muscle stretching of the UL with restriction. The non-paretic UL mobilisation will be performed by using traction techniques and joint circular movements, with 30 repetitions for each joint. All muscle groups of the UL will be submitted to stretching. A series of 3 repetitions consisted of keeping the extension pressure for 45 seconds will be performed. This procedure enabled the patient to have unrestricted movements for at least 60 minutes. Then, another immobilisation will be prepared using a new tubular mesh.
Only the patients in the CIMT group attended an exercise training program for 5 days a week during the whole experimental period. Each session will last 50 minutes on average. The program will follow a protocol consisting of kinesiotherapy and functional manual tasks for paretic UL. Each session will includ a 5-10-minute warm-up period, scapula mobilisation, flexion exercises and shoulder abduction, flexion exercises and elbow extension, flexion movements, trunk extension and rotation associated with upper limb movements, flexion exercises and wrist extension, and functional activities such as unlocking a door, typing a telephone number, turning on the tap, turning off the light, among other tasks.The protocol will be applied to paretic UL only, whereas the non-paretic UL will be under no restriction of movements. The exercises will be performed at maximum range, and whenever possible with some resistance by the physiotherapist. The sessions will be consisted of three series of 10 repetitions of each exercise. The rest interval between the exercises will be determined for each individual patient in order to avoid fatigue and excessive tiredness. In the both groups LL will be not stimulated.
Intervention code [1] 257795 0
Rehabilitation
Comparator / control treatment
The Forced Use Therapy will be the control treatment. As described above the immobilisation, mobilisation, and stretching of the non-paretic UL will be the same that CIMT. The only difference is the estimulation protocol.
Immobilisation will be performed by means of a tubular mesh involving the non-paretic UL on abduction, rotating the shoulder internally, and allowing elbow flexion above 90 degrees. Immobilisation will be maintained for 24 hours during five days a week over a period of four weeks. The tubular mesh will be removed every day by the examiners for hygienisation, mobilisation, and muscle stretching of the UL with restriction. The non-paretic UL mobilisation will be performed by using traction techniques and joint circular movements, with 30 repetitions for each joint. All muscle groups of the UL were submitted to stretching. A series of 3 repetitions consisted of keeping the extension pressure for 45 seconds were performed. This procedure will enable the patient to have unrestricted movements for at least 60 minutes. Then, another immobilisation will be prepared using a new tubular mesh.
Control group
Active

Outcomes
Primary outcome [1] 259878 0
Lower limb function will be evaluated by using the Berg Balance Scale (BBS) and Fugl-Meyer Assessment of Motor Recovery (FMA).
The BBS assesses balance performance on 14 items. Each item has an ordinal scale of five alternatives ranging from 0 to 4 points. Therefore, the maximum score is 56 points.
The FMA evaluates the sensorimotor recovery of UL and LL post-stroke. The maximum scores are 66 and 34 points for upper and lower limbs, respectively, which defines a normal motor functio. In this case we only will use the 34 score.
Timepoint [1] 259878 0
Motor evaluation will be performed on a weekly basis during the 4-week experimental period and every 30 days after protocol for further three months. In this way, it will be carried out an initial evaluation (start), three weekly evaluations (1st, 2nd, and 3rd weeks), one final evaluation (4th week), and three follow-up evaluations (1st, 2nd, and 3rd months of follow-up).
Primary outcome [2] 266561 0
Gait analysis will be performed by using the 10-metre walk test (10mT) and Time-UP & Go test (TUG). The 10mT evaluates the time in seconds to walking a distance of 10 metres. The subjects will be instructed to conduct the test quickly and safely. In our work, the execution time of each evaluation test will be performed twice and this resulted in an average. TUG test measured (in seconds) the time the subject need to rise from a chair and walk a distance of 3 meters, return and sit down, without any assistance.
For both tests, the data of the start assessment will be normalized in percentage, corresponding to 100% of the time required to perform the test. Assessments of 1st, 2nd, and 3rd and 4th weeks, and 1st, 2nd, and 3rd months of follow-up, also will be normalized into the percentage, concerning the percentage of the start assessment.
Timepoint [2] 266561 0
Motor evaluation will be performed on a weekly basis during the 4-week experimental period and every 30 days after protocol for further three months. In this way, it will be carried out an initial evaluation (start), three weekly evaluations (1st, 2nd, and 3rd weeks), one final evaluation (4th week), and three follow-up evaluations (1st, 2nd, and 3rd months of follow-up).
Secondary outcome [1] 268754 0
The Stroke Impact Scale (SIS) version 3.037 will be used with the patients during their admission. SIS scale integrates significant dimensions of function and quality of life in a self-report. The version used has 59 questions and evaluates 8 domains (strength, hand function, performance and independence in activities of daily living, mobility, communication, emotion, memory and thought) with a maximum score of 295 points. In our study, we used only the items that assess the performance of activities of daily living, lower limb strength and locomotion (walking and transfers), resulting in a maximum score of 80 points.
Timepoint [1] 268754 0
This scale will be used during start and finish of the treatment (4th week), and in the follow up, 1st, 2nd, and 3rd months after the ending of the protocol.

Eligibility
Key inclusion criteria
Hemiparesis, good cognition function, absence of joint blockage, preserved amplitude movement (AM), ability to ambulate alone, and upper lower movement at 20 and 10 degrees of active extension for wrist and metacarpophalangeal joint, respectively.
Minimum age
35 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac arrhythmias, non-controlled blood pressure, and severe respiratory and cardiovascular problems.
Medications for treatment of stroke and hypertension will be accepted.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
For randomization we wil use 40 sealed envelopes with the indication for an experimental treatment group. Each envelopes contains only one type of treatment. Each patient can freely choose a sealed envelope containing the assignment to an experimental group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using 40 envelopes with one of these two therapies inside. There are 20 with constraint-induced movement therapy and 20 with forced use therapy. After sealed the envelope, they were shuffled and put in a box. In the moment that the patient accepts make part of this study, he os she can choose any envelope inside the box.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3103 0
Brazil
State/province [1] 3103 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 258266 0
Government body
Name [1] 258266 0
FAPESP
Country [1] 258266 0
Brazil
Primary sponsor type
University
Name
School of Medicine – University of Sao Paulo, Ribeirao Preto (USP-RP)
Address
Avenida dos Bandeirantes 3900, Monte Alegre
CEP: 14049-900, Ribeirao Preto - SP
Brasil
Country
Brazil
Secondary sponsor category [1] 257432 0
None
Name [1] 257432 0
Address [1] 257432 0
Country [1] 257432 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260241 0
Ethics in research and human experimentation of the teaching Hospital of the Faculty of Medicine of the Sao Paulo University
Ethics committee address [1] 260241 0
Ethics committee country [1] 260241 0
Brazil
Date submitted for ethics approval [1] 260241 0
20/06/2006
Approval date [1] 260241 0
31/08/2006
Ethics approval number [1] 260241 0
5995/2006

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

Contacts
Principal investigator
Name 32035 0
Address 32035 0
Country 32035 0
Phone 32035 0
Fax 32035 0
Email 32035 0
Contact person for public queries
Name 15282 0
Joao Eduardo De Araujo
Address 15282 0
Laboratory of Bioengineering, Neuropsychobiology and Motor Behavior, Department of Biomechanics, Medicine and Rehabilitation of the Locomotor System, School of Medicine – University of Sao Paulo, Ribeirao Preto (USP-RP), Avenida dos Bandeirantes 3900, Ribeirao Preto (SP) 14049-900, Brazil
Country 15282 0
Brazil
Phone 15282 0
55+1636024416
Fax 15282 0
55+1636024413
Email 15282 0
[email protected]
Contact person for scientific queries
Name 6210 0
Joao Eduardo De Araujo
Address 6210 0
Laboratory of Bioengineering, Neuropsychobiology and Motor Behavior, Department of Biomechanics, Medicine and Rehabilitation of the Locomotor System, School of Medicine – University of Sao Paulo, Ribeirao Preto (USP-RP), Avenida dos Bandeirantes 3900, Ribeirao Preto (SP) 14049-900, Brazil
Country 6210 0
Brazil
Phone 6210 0
55+1636024416
Fax 6210 0
55+1636024413
Email 6210 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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