Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06184191
Status:
COMPLETED
Last Update Posted:
2023-12-28
First Post:
2023-12-07
Brief Title:
Combined Robotic Hand Rehabilitation and Conventional Rehabilitation for Post-stroke Rehabilitation
Sponsor:
Gaziosmanpaşa Training and Research Hospital University of Health Sciences
Organization:
Gaziosmanpaşa Training and Research Hospital University of Health Sciences
Study Overview
Official Title:
Comparison of the Effects of Combined and Individual Robotic Hand Rehabilitation and Conventional Rehabilitation on Daily Living Activity Upper Extremity Functional Results and Hand Strength in Patients With Post-stroke Hemiplegia
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective The investigators compared the effectiveness of individual and combined application of conventional rehabilitation and robotic hand rehabilitation in post-stroke hemiplegia The study design is an An assessor-blinded prospective randomized comparison study
Methods Patients were randomly assigned to one of three groups
Group 1 Robotic Hand Rehabilitation The patients underwent robotic hand rehabilitation Group 2 Conventional Rehabilitation The patients underwent conventional rehabilitation Group 3 Combined Rehabilitation The patients underwent combined conventional and robotic hand rehabilitation at the same period
Randomization was performed using the closed envelope method randomization sequence by an investigator who was not involved in patient care The therapist opened the envelope 6 hours before the patient started treatment
The investigators assessed Barthel index for activities of daily living range 0 - 100 Brunnstroms hemiplegia recovery staging range stage 1 - stage 7 Fugl-Meyer upper extremity assessment scale stage 0 - 66 Abilhand stroke hand ability questionnaire assessment range 0 - 46 hand grip strength and hand pinch strength at baseline and end of the rehabilitation 1-month
Conclusions There are many studies in the literature on the hand and upper extremity functions of Conventional Rehabilitation and Robotic Hand Rehabilitation in stroke They revealed that both therapies had a positive effect on the results There is no study on the effect of combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions More successful hand functional results may be achieved by applying both rehabilitations together in stroke The aim of our study is to compare the effects of early-term individually and concomitant Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions and hand strength in stroke Our hypothesis is that the combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation together will provide better functional results of the hand and upper extremity
Methods Patients were randomly assigned to one of three groups
Group 1 Robotic Hand Rehabilitation The patients underwent robotic hand rehabilitation Group 2 Conventional Rehabilitation The patients underwent conventional rehabilitation Group 3 Combined Rehabilitation The patients underwent combined conventional and robotic hand rehabilitation at the same period
Randomization was performed using the closed envelope method randomization sequence by an investigator who was not involved in patient care The therapist opened the envelope 6 hours before the patient started treatment
The investigators assessed Barthel index for activities of daily living range 0 - 100 Brunnstroms hemiplegia recovery staging range stage 1 - stage 7 Fugl-Meyer upper extremity assessment scale stage 0 - 66 Abilhand stroke hand ability questionnaire assessment range 0 - 46 hand grip strength and hand pinch strength at baseline and end of the rehabilitation 1-month
Conclusions There are many studies in the literature on the hand and upper extremity functions of Conventional Rehabilitation and Robotic Hand Rehabilitation in stroke They revealed that both therapies had a positive effect on the results There is no study on the effect of combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions More successful hand functional results may be achieved by applying both rehabilitations together in stroke The aim of our study is to compare the effects of early-term individually and concomitant Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions and hand strength in stroke Our hypothesis is that the combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation together will provide better functional results of the hand and upper extremity
Detailed Description:
Objective Hemiplegia or hemiparesis is commonly seen after strokeUpper limb function particularly hand function plays a crucial role in determining the quality of life and independence after stroke Numerous studies have been conducted on rehabilitation to improve upper extremity functionThere are many studies in the literature on the hand and upper extremity functions of Conventional Rehabilitation and Robotic Hand Rehabilitation in stroke They revealed that both therapies had a positive effect on the results There is no study on the effect of combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions More successful hand functional results may be achieved by applying both rehabilitations together in stroke The aim of our study is to compare the effects of early-term individually and concomitant Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions and hand strength in stroke Our hypothesis is that the combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation together will provide better functional results of the hand and upper extremity
Methods 66 patients with post-stroke hemiplegia will include in our study Grip strength was measured with a dynamometer JamarR PrestonTM Jackson MI and pinch strength was measured with a specially designed instrument Pinch gauge BR EngineeringTM Santa Fe Springs CA Measurements were made 3 times and the average value was taken The patients were evaluated before rehabilitation and at the first month follow-up The same therapist who was blind to the type of rehabilitation evaluated the patients before treatment and at the first month follow-up
Conclusions Combined Rehabilitation achieves results just as successful as Conventional Rehabilitation in terms of daily living activities upper extremity functions and hand functions Additionally it significantly outperformed Conventional Rehabilitation in improving hand functions treating hand spasticity and enhancing hand strength
Methods 66 patients with post-stroke hemiplegia will include in our study Grip strength was measured with a dynamometer JamarR PrestonTM Jackson MI and pinch strength was measured with a specially designed instrument Pinch gauge BR EngineeringTM Santa Fe Springs CA Measurements were made 3 times and the average value was taken The patients were evaluated before rehabilitation and at the first month follow-up The same therapist who was blind to the type of rehabilitation evaluated the patients before treatment and at the first month follow-up
Conclusions Combined Rehabilitation achieves results just as successful as Conventional Rehabilitation in terms of daily living activities upper extremity functions and hand functions Additionally it significantly outperformed Conventional Rehabilitation in improving hand functions treating hand spasticity and enhancing hand strength
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None