Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06010823
Status:
RECRUITING
Last Update Posted:
2023-09-22
First Post:
2023-08-20
Brief Title:
Safety and Efficacy Evaluation of the Robotic Enhanced Error Training of Upper Limb Function in Post-stroke and Post TBI Participants
Sponsor:
Reuth Rehabilitation Hospital
Organization:
Reuth Rehabilitation Hospital
Study Overview
Official Title:
A Prospective Randomized Open-label Two-arms Multi Center Feasibility Study to Evaluate the Safety and Efficacy of the PlaXtreme Device for Rehabilitation of the Hand in Post-stroke and Post TBI Participants
Status:
RECRUITING
Status Verified Date:
2023-08
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:
Background Cerebrovascular accident CVA or commonly known as stroke and traumatic brain injury TBI are common causes of morbidity and motor impairments Many stroke and TBI patients encounter severe functional impairments of their arm andor hand Recent studies have indicated that robotic training can improve upper limb function by enabling repetitive adaptive and intensive training
One type of robotic training is error enhancement during three-dimensional movements The goal of this approach is to elicit better accuracy stability fluidity and range of motion during reaching
Previous research indicated the potential of robotic training with error enhancement as a viable clinical intervention for individuals facing motor deficits
Objectives To evaluate the safety and efficacy of a new robotic system based on error enhancement and intended for rehabilitation of motor hand functions of post-stroke and TBI patients
Methods A randomized multi-center study with an open-label design The study sample will consist of 96 participants who will be randomized into 2 separate groups The intervention group consisting of 48 patients will receive training with the new robotic system while the control group consisting of additional 48 patients will receive only standard practice treatments with no exposure to the new robotic system The outcomes of safety adverse events and treatment tolerability and efficacy motor function speed tone and spasticity will be assessed and compared between the two groups The assessment of the outcomes will be conducted at four different time points 1 prior to the initiation of the four-week intervention 2 after 2 weeks of intervention 3 at the conclusion of the intervention and 4 at a three-month follow-up session
One type of robotic training is error enhancement during three-dimensional movements The goal of this approach is to elicit better accuracy stability fluidity and range of motion during reaching
Previous research indicated the potential of robotic training with error enhancement as a viable clinical intervention for individuals facing motor deficits
Objectives To evaluate the safety and efficacy of a new robotic system based on error enhancement and intended for rehabilitation of motor hand functions of post-stroke and TBI patients
Methods A randomized multi-center study with an open-label design The study sample will consist of 96 participants who will be randomized into 2 separate groups The intervention group consisting of 48 patients will receive training with the new robotic system while the control group consisting of additional 48 patients will receive only standard practice treatments with no exposure to the new robotic system The outcomes of safety adverse events and treatment tolerability and efficacy motor function speed tone and spasticity will be assessed and compared between the two groups The assessment of the outcomes will be conducted at four different time points 1 prior to the initiation of the four-week intervention 2 after 2 weeks of intervention 3 at the conclusion of the intervention and 4 at a three-month follow-up session
Detailed Description:
Background Stroke and traumatic brain injury TBI are leading causes for morbidity hospitalization and extended injury of motor system as well as movement learning It has been proven that roughly 85 of stroke survivors suffer from weakness in their upper limbs and around 40 of stroke survivors will suffer from severe handicap in their paretic arm negatively affecting their independence and quality of life Statically about 50 - 70 of survivors will recover enough to enable daily use of their arm These numbers indicate that although rehabilitation for stroke patients is evident there remains a need for more effective methods
Traditional rehabilitative methods are often time-consuming and labor-intensive Only a few of these methods induce slightly improved arm function and a full recovery is often not achieved Recently studies have indicated that robotic training has promise for improving functional abilities among stroke survivors by enabling repetitive adaptive intensive and accurate control of task complexity during the rehabilitation period One type of robotic training that is particularly promising is error enhancement this utilizes the adaptive capabilities of the nervous system to improve fine motor function of the arm
Study Objectives To evaluate the change in the upper limb function amongst post-stroke and post-TBI patients undergoing error enhancement treatment compared to a control group in the following domains
1 Motor Function Fugl-Meyer Assessment Action Research Arm Test ARAT pinch and grip tests
2 Speed Box and Blocks Assessment
3 Tone and Spasticity Modified Ashworth Scale
In addition this study will examine the safety and patient tolerability of the device
Methods Population A total of 96 participants will be recruited within 3 medical centers participating in the study The recruitment will take place between 14 days and up to 18 months after the onset of the stroke or brain injury
Recruitment Electronic medical records of newly hospitalized patients will be screened to identify potential study participants All eligible patients will be offered to participate After obtaining informed consent an intake session will take place for screening and evaluation purposes conducted by a qualified occupational therapist Patients successfully passing the screening session will undergo randomization to one of the two study arms with 11 ratio in each of the medical centers conducting the study
All the treatments will be conducted a separate occupational therapist who will be blinded to the patient allocation group Patients in the intervention arm will undergo training sessions with the robotic device 3 times a week for a period up to 4 weeks while the patients in the control arm will receive standard rehabilitative care
Patients in both groups will undergo additional evaluation sessions at the following time points after 2 weeks of intervention at the conclusion of the intervention 4 weeks and at a three-month follow-up session
Traditional rehabilitative methods are often time-consuming and labor-intensive Only a few of these methods induce slightly improved arm function and a full recovery is often not achieved Recently studies have indicated that robotic training has promise for improving functional abilities among stroke survivors by enabling repetitive adaptive intensive and accurate control of task complexity during the rehabilitation period One type of robotic training that is particularly promising is error enhancement this utilizes the adaptive capabilities of the nervous system to improve fine motor function of the arm
Study Objectives To evaluate the change in the upper limb function amongst post-stroke and post-TBI patients undergoing error enhancement treatment compared to a control group in the following domains
1 Motor Function Fugl-Meyer Assessment Action Research Arm Test ARAT pinch and grip tests
2 Speed Box and Blocks Assessment
3 Tone and Spasticity Modified Ashworth Scale
In addition this study will examine the safety and patient tolerability of the device
Methods Population A total of 96 participants will be recruited within 3 medical centers participating in the study The recruitment will take place between 14 days and up to 18 months after the onset of the stroke or brain injury
Recruitment Electronic medical records of newly hospitalized patients will be screened to identify potential study participants All eligible patients will be offered to participate After obtaining informed consent an intake session will take place for screening and evaluation purposes conducted by a qualified occupational therapist Patients successfully passing the screening session will undergo randomization to one of the two study arms with 11 ratio in each of the medical centers conducting the study
All the treatments will be conducted a separate occupational therapist who will be blinded to the patient allocation group Patients in the intervention arm will undergo training sessions with the robotic device 3 times a week for a period up to 4 weeks while the patients in the control arm will receive standard rehabilitative care
Patients in both groups will undergo additional evaluation sessions at the following time points after 2 weeks of intervention at the conclusion of the intervention 4 weeks and at a three-month follow-up session
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