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Effects of Training Rhythmic and Discrete Aiming Movements on Arm Control and Functionality After Stroke

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ClinicalTrials.gov Identifier: NCT02765152
Recruitment Status : Unknown
Verified January 2017 by Renata Morales Banjai, Universidade Cidade de Sao Paulo.
Recruitment status was:  Recruiting
First Posted : May 6, 2016
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Renata Morales Banjai, Universidade Cidade de Sao Paulo

Brief Summary:
The purpose of this study is to verify the additional effects of rhythmic specific training, discrete specific training additional to conventional therapy on the upper limb after chronic stroke subjects on the outcomes: motor control and functionality.

Condition or disease Intervention/treatment Phase
Stroke Other: Conventional Physical Therapy Other: Discrete movement training group Other: Rhythmic movement training group Not Applicable

Detailed Description:

Seventy-five patients will be randomized into three groups to receive conventional therapy, consisting of a combination of mobility exercises joint, muscle stretching, strength training, motor coordination exercises, unilateral and bilateral motor tasks as well as oriented tasks training upper limb with a focus on functional tasks. The other groups will receive additional intervention consisting of aiming movement practice according two different protocols: discrete movements to targets placed in different directions and distances; and rhythmic movements also to targets placed in different directions and distances. Both additional interventional interventions will be conducted for 30 minutes over a 5 week-period (total: 10 sessions).

Clinical outcomes (motor control), functional and kinematic will be collected at baseline and at five weeks. Functional results will be collected at the beginning, after 5 weeks and 3 months after randomization. Data will be collected by a blinded assessor on patients' allocation group. All statistical analyzes will be carried out following the principles of intention to treat analysis and differences between groups will be performed using linear mixed models.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Training Rhythmic and Discrete Aiming Movements on the Upper Limb Control and Functionality After Stroke: Randomized Controlled Trial
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Active Comparator: Conventional Physical Therapy
Usual therapy: joint mobility exercises, stimulating joint movement of the main active components of the upper limb; major muscle groups stretching, especially in the affected muscles by tone impairment; manual resistance training according to the degree of the patient's muscle strength, prioritizing the functional specificity of the upper limb, so the majority of the exercises will be held in open chain; motor coordination exercises, unilateral and bilateral motor tasks as well as task-oriented training of the upper limb with a focus on functional tasks.
Other: Conventional Physical Therapy
Combination of joint mobility exercises, specific exercises for muscle strength and motor coordination exercises, unilateral and bilateral motor tasks as well as task-oriented training of the upper limb with a focus on functional tasks. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week)

Experimental: discrete movement training group
Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The starting point of the movement and its target are predetermined. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.
Other: Discrete movement training group
Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The starting point of the movement and its target are predetermined. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.

Experimental: rhythmic movement training group
Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The movement begins in a predetermined starting point, directed to a target and returns to the starting point. This activity is performed several times with rhythmic movements. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.
Other: Rhythmic movement training group
Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The movement begins in a predetermined starting point, directed to a target and returns to the starting point. This activity is performed several times with rhythmic movements. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.




Primary Outcome Measures :
  1. Stroke Impact Scale (SIS) [ Time Frame: Five weeks after randomization and 3 months after randomization ]
    Functionality: questionnaire which evaluates functionality. In this study will be evaluated four areas (arm muscle strength, hand function, activities of daily living and social participation)(Duncan et al., 1999). Each domain is scored from 1 to 5 (1 point corresponds to the worst possible outcome and 5 points to the best result). For the four areas the lowest possible score is 28 points and the highest is 125 points.


Secondary Outcome Measures :
  1. Motor Activity Log (MAL) [ Time Frame: Five weeks and 3 months after randomization ]

    Arm function: individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 30 daily functional tasks (original MAL) (Uswatte et al., 2005).

    Items scored on a 6-point ordinal scale, where 0 corresponds to the weaker arm was not sued at all for that activity (never). Patients with a score 5 show the ability to use the weaker arm for that activity was as good as before the stroke (normal).


  2. Fugl-Meyer Assessment Scale [ Time Frame: Five weeks after randomization ]
    Motor control: this scale assesses sensorimotor function of upper limb, with score 0-66 points with scores 0-66 points for motor function and 0-126 points for sensory-motor function (Fugl-Meyer, 1975). A higher score is better motor function.


Other Outcome Measures:
  1. kinematics assessment [ Time Frame: Five weeks after randomization ]
    Functional capacity: It will be used an experimental apparatus that analyzes the motor behavior the aiming movement (Ribeiro et al., 2014). They will evaluate the movement time (measured in milliseconds), reaction time (in milliseconds) and smoothness (expressed in units of motion). The movement time is the time interval between the beginning and the end of the movement. Reaction time is defined as the time between the start of the imperative stimulus to the beginning of the movement. The smoothness is evaluated by computing the number of times the acceleration zero crossing (positive to negative and vice versa). The resultant variable error (in centimeters) is a measure of variability for both the medial-lateral direction as anteroposterior, assessing the accuracy to hit the target.

  2. Grip strength [ Time Frame: Five weeks after randomization ]
    Body function and structure: it will measure the strength of grip and pinch through dynamometer. The results will be presented in kilogram-force (Kgf) (Mathiowetz et al., 1985)

  3. Modified Ashworth Spasticity Scale [ Time Frame: Five weeks after randomization ]
    Body function and structure: they will be assessed flexors elbow, wrist and fingers, and forearm pronators. A measurement scale from 0 to 4 points, with 0 representing normal muscle tone and 4 is the highest possible degree of spasticity (Bohannon and Smith, 1987)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:patients who participate in the survey, adult stroke survivors (>18 years), with primary diagnosis of first-ever unilateral stroke (ischaemic or haemorrhagic), stroke experienced > 6 months prior to study enrollment and score ≥ 20 on the Folstein Mini Mental Status Examination.

Exclusion criteria: patients with excessive pain in the paretic hand, arm or shoulder excessive spasticity at the paretic elbow and wrist as defined as a score of 4 on the Modified Ashworth Spasticity Scale and upper limb comorbidities that could limit their functional recovery (e.g., arthritis, pain, other neurological disorders).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765152


Contacts
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Contact: Sandra R Alouche, PhD +551121781565 sandra.alouche@unicid.edu.br
Contact: Leonardo OP Costa, PhD +551121781565 leonardo.costa@unicid.edu.br

Locations
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Brazil
Universidade Cidade de Sao Paulo Recruiting
Sao Paulo, Brazil, 03071-000
Contact: Sandra R Alouche, PhD    +551121781565    sandra.alouche@unicid.edu.br   
Sponsors and Collaborators
Universidade Cidade de Sao Paulo
Investigators
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Study Director: Sandra R Alouche, PhD Universidade Cidade São Paulo
Publications:

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Responsible Party: Renata Morales Banjai, Principal Investigator, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT02765152    
Other Study ID Numbers: Universidade Cidade Sao Paulo
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Renata Morales Banjai, Universidade Cidade de Sao Paulo:
exercise
rhythmic movement
discrete movement
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases