Clinical trial NCT06571292: Effectiveness of Intensive Training in Upper Limb Rehabilitation After Stroke.
Official title: Effectiveness of Dose-intensity Therapy in Post-stroke Upper Limb Rehabilitation: an Occupational Therapy Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
intensive training
upper limb
occupational therapy
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 16
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 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.

Detailed description: Abtract

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

Methods: 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. The primary outcome measure include is the Fugl Meyer Assessment (FMA).Secondary measures include the Box and Blocks Test (BBT), dynamometer, Motor Activity Log (MAL), Stroke Impact Scale (SIS), Functional Independence Measure (FIM) and Canadian Occupational Performance Measure (COPM).

Assessments occur at baseline, after 4 weeks of intervention, and at 1 month after intervention commencement. Analysis will be intention to treat using a generalised linear mixed model to report estimated mean differences in scores between the two groups at each timepoint with 95% confidence Interval and value p.

Hypothesis: If an intensive training programme is effective in improving upper limb motor function, its implementation for clinical practice could be beneficial for improving upper limb motor function and quality of life in people who have suffered a stroke.

Eligibility criteria: Inclusion Criteria:

* People diagnosed with stroke (ischaemic or haemorrhagic).
* Patients in a subacute or chronic state.
* Patients must be over 18 years of age and under 80 years of age.
* Patients with impaired functionality of the upper limb.

Exclusion Criteria:

* Persons diagnosed with other pathologies, other than those indicated in the inclusion criteria.
* Mini-Mental State Examination (MMSE), the minimum score to be achieved will be 22 points.
* Severe difficulties in understanding language (aphasia).
* Behavioural or behavioural disturbance.
* Treatment with botulinum toxin 3 months prior to the intervention.

Primary outcomes:
measure: Fugl Meyer Assesment (FMA)
timeFrame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement
Secondary outcomes:
measure: Box and Blocks Test (BBT)
timeFrame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
measure: Dynamometer
timeFrame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
measure: Motor Activity Log (MAL)
timeFrame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
measure: Stroke Impact Scale (SIS). To assess physical function following stroke. ICF Domain Activity. Minimal Detectable Change (MDC)MDC >= 8
timeFrame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
measure: Funcitonal Independence Measure (FIM)
timeFrame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Other outcomes:
measure: Montreal Cognitive Assesment (MOCA)
timeFrame: Prior to the baseline assessment
Locations:
city: Zaragoza
country: Spain
facility: University of Zaragoza
Study officials:
References: