Clinical trial NCT02765152: Effects of Training Rhythmic and Discrete Aiming Movements on Arm Control and Functionality After Stroke
Official title: Effects of Training Rhythmic and Discrete Aiming Movements on the Upper Limb Control and Functionality After Stroke: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: exercise
rhythmic movement
discrete movement
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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).

Primary outcomes:
measure: Stroke Impact Scale (SIS)
timeFrame: Five weeks after randomization and 3 months after randomization
Secondary outcomes:
measure: Motor Activity Log (MAL)
timeFrame: Five weeks and 3 months after randomization
measure: Fugl-Meyer Assessment Scale
timeFrame: Five weeks after randomization
Other outcomes:
measure: kinematics assessment
timeFrame: Five weeks after randomization
measure: Grip strength
timeFrame: Five weeks after randomization
measure: Modified Ashworth Spasticity Scale
timeFrame: Five weeks after randomization
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Cidade de Sao Paulo
Study officials:
affiliation: Universidade Cidade São Paulo
name: Sandra R Alouche, PhD
role: STUDY_DIRECTOR
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