Effects of Training Rhythmic and Discrete Aiming Movements on the Upper Limb Control and Functionality After Stroke: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Stroke Impact Scale (SIS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
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.
Intervention: Conventional Physical Therapy (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.
Intervention: Discrete movement training group (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.
Intervention: Rhythmic movement training group (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Fugl-Meyer Assessment Scale(Five weeks after randomization)
- Motor Activity Log (MAL)(Five weeks and 3 months after randomization)
Investigators
Renata Morales Banjai
Principal Investigator
Universidade Cidade de Sao Paulo