The aim of the study is to analyse the effect of intensive training on upper limb function in stroke patients. 20 stroke patients were randomly divided into two groups: the intensive group and the control group. The control group will be trained with robotic exoskeleton for upper limbs and task specific training, 3 sessions per week for 4 weeks, for 1 hour per day. The intensive group will do robotic exoskeleton for upper limbs and task specific training, 5 sessions a week for 4 weeks, for 2 hours a day.
Abtract Introduction: Intensive rehabilitation and task-specific training (TST) are essential for recovery after stroke. Devices such as Armeo Spring allow for increased repetitions while maintaining specificity. The objective was to compare the effect of a high-repetition dose versus a low-repetition dose using a combined program of Armeo Spring and TST on upper limb recovery in patients with chronic stroke. Methods: Randomized, single-blind clinical trial with 20 participants (\>6 months post-stroke). Participants were assigned to two groups: High Repetition (HR; 40 hours total, 2 hours/session, 5 days/week) and Low Repetition (LR; 12 hours total, 1 hour/session, 3 days/week) for 4 weeks. The primary outcome measure was the Fugl-Meyer Assessment-Upper Extremity (FMA-UE). Assessments were performed at baseline (T0), post-intervention (T1), and one month (T2). Results: Both groups showed significant improvements in the FMA-UE (p \< 0.01). The HR group improved by 10.80 points (SD = 5.92) and the BR group by 5.90 points (SD = 3.54) at T1 and remained stable at T2. The intergroup comparison significantly favored the HR group at T1 and T2 (p \< 0.02), with superior benefits also in dexterity, independence, and perception of performance. The effect size was greater in the HR group (d = 0.712) than in the LR group (d = 0.435) between T0 and T1, but at T2, the effect size was small in both groups. Conclusions: Armeo Spring therapy and high-repetition TST proved to be more effective in improving upper limb functionality in patients with chronic stroke at the end of the intervention and at the one-month follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Both groups will be trained with robotic exoskeleton for upper limbs and task specific training.
Both groups will be trained with robotic exoskeleton for upper limbs and task specific training.
University of Zaragoza
Zaragoza, Spain
Fugl Meyer Assesment (FMA)
Primary Outcome Measure. It is a scale where the area of assessment includes ADLs, functional mobility and pain. ICF Domain, Body Function.Minimal Detectable Change (MDC) FMA = 5.2 points for the Upper Extremity portion of the assessment
Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement
Box and Blocks Test (BBT)
Secondary Outcome Measures.Assesses unilateral gross manipulative skills.ICF Domain Activity.Minimal Detectable Change (MDC)MDC: 5.5 blocks per minute
Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Dynamometer
Secondary Outcome Measures.A quantitative and objective measure of isometric muscular strength of the hand and forearm. ICF Domain Body Structure Body Function. Minimally Clinically Important Difference (MCID) 5.0 and 6.2 (kg) for the affected dominant and non-dominant sides.
Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Motor Activity Log (MAL)
Secondary Outcome Measures. The MAL is a semi-structured interview to assess arm function. ICF Domain Activity Participation. Minimal Detectable Change (MDC)MDC= 0.56- 1.06
Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Stroke Impact Scale (SIS). To assess physical function following stroke. ICF Domain Activity. Minimal Detectable Change (MDC)MDC >= 8
Secondary Outcome Measures
Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
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Funcitonal Independence Measure (FIM)
Secondary Outcome Measures. Provides a uniform system of measurement for disability based on the International Classification of Impairment, Disabilities and Handicaps; measures the level of a patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living.ICF Domain Activity. Minimally Clinically Important Difference (MCID) FIM Total Score = 22 points
Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Canadian Occupational Performance Measure (COPM)
Secondary Outcome Measures. The COPM assesses an individual's perceived occupational performance in the areas of self-care, productivity, and leisure.ICF Domain Participation.Minimal Detectable Change (MDC) MDC for performance=1.7 points MDC for satisfaction=2.7 points
Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.