Effectiveness of Intensive Training in Upper Limb Rehabilitation After Stroke.
NCT ID: NCT06571292
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
16 participants
INTERVENTIONAL
2024-07-05
2024-10-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Both the principal investigator and the investigators of the interventions will be blinded to the data of the measurements that have been taken, and must leave the room during the assessment period.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Intensive training with robotic exoskeleton for upper limbs
Both groups will be trained with robotic exoskeleton for upper limbs and task specific training.
Task specific training
Both groups will be trained with robotic exoskeleton for upper limbs and task specific training.
Intensive group
The intensive group will be trained with robotic exoskeleton for upper limbs and task specific training, 5 sessions per week for 4 weeks, for 2 hours per day.
Intensive training with robotic exoskeleton for upper limbs
Both groups will be trained with robotic exoskeleton for upper limbs and task specific training.
Task specific training
Both groups will be trained with robotic exoskeleton for upper limbs and task specific training.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intensive training with robotic exoskeleton for upper limbs
Both groups will be trained with robotic exoskeleton for upper limbs and task specific training.
Task specific training
Both groups will be trained with robotic exoskeleton for upper limbs and task specific training.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad de Zaragoza
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Enrique Villa Berges
PhD Principal investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Zaragoza
Zaragoza, Zaragoza, Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
University Zaragoza
Identifier Type: -
Identifier Source: org_study_id