Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571292
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Effectiveness of Intensive Training in Upper Limb Rehabilitation After Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Intensive Training in Upper Limb Rehabilitation After Stroke An Occupational Therapy Approach
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 FMASecondary 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
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 FMASecondary 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None