Effectiveness of Intensive Training in Upper Limb Rehabilitation After Stroke.
NCT Number: NCT06571292
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: DEVICE: Intensive training with robotic exoskeleton for upper limbs|DEVICE: Task specific training
Sponsor: Universidad de Zaragoza
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-05
Completion Date: 2024-10-04
Locations: University of Zaragoza, Zaragoza, 50009, Spain

Summary:
The aim of the study is to analyse the effect of intensive training on upper limb function in stroke patients.

16 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.

Primary Outcome Measures: 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, Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement
Secondary Outcome Measures: 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, 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., 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, 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, Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.|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, 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, Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Other Outcome Measures: Montreal Cognitive Assesment (MOCA), Exclusion criterio. Rapid screen of cognitive abilities designed to detect mild cognitive dysfunction., Prior to the baseline assessment