Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-24 @ 3:24 PM
NCT ID:
NCT06571292
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.
Study:
NCT06571292
Study Brief:
Protocol Section:
NCT06571292