Ignite Creation Date:
2024-05-06 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05174676
Status:
UNKNOWN
Last Update Posted:
2022-01-04
First Post:
2021-11-29
Brief Title:
Robotic Enhanced Error Training of Upper Limb Function in Post-stroke Patients
Sponsor:
Reuth Rehabilitation Hospital
Organization:
Reuth Rehabilitation Hospital
Study Overview
Official Title:
Robotic Enhanced Error Training of Upper Limb Function in Post-stroke Patients A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
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 Stroke is a common cause of morbidity including paresis and stroke survivors often have reduced function in their paretic arm Many do not regain full recovery of their arm function which negatively impacts their quality of life Recent studies have indicated that robotic training may improve upper limb function abilities among stroke survivors by enabling repetitive adaptive and intensive training and more accurate control of task complexity Robotic training in addition to standard rehabilitative care has shown promise for improving functional skills among stroke survivors One type of robotic training is error enhancement whereby an error made by the patient is exaggerated increasing the signal to noise ratio which causes errors to be more noticeable This in turn enhances movement correction Previous studies have found that error enhancement has promise as a clinical treatment for patients with motor deficits
Objectives This study aims to evaluate the effect of a robotic device DeXtreme on the functional capabilities of the paretic arm of stroke survivors This device aims to improve arm function by utilizing error enhancement techniques
Methods A double-blind randomized placebo-controlled study comparing treatment outcomes between two groups to assess the effect of error enhancement robotic training on functional use of the arm and hand in patients after stroke Forty stroke patients will undergo 6 sessions of 25 minutes each with the Dextreme device One group will receive training with error enhancement forces applied while the control group will receive similar training without error enhancement Outcomes motor function speed tone and spasticity will be assessed twice prior to and following the treatment sessions
Objectives This study aims to evaluate the effect of a robotic device DeXtreme on the functional capabilities of the paretic arm of stroke survivors This device aims to improve arm function by utilizing error enhancement techniques
Methods A double-blind randomized placebo-controlled study comparing treatment outcomes between two groups to assess the effect of error enhancement robotic training on functional use of the arm and hand in patients after stroke Forty stroke patients will undergo 6 sessions of 25 minutes each with the Dextreme device One group will receive training with error enhancement forces applied while the control group will receive similar training without error enhancement Outcomes motor function speed tone and spasticity will be assessed twice prior to and following the treatment sessions
Detailed Description:
Background At least 85 of stroke survivors suffer from weakness in their upper limbs Around 40 of stroke survivors will suffer from severe handicap in their paretic arm negatively affecting their independence and quality of life Only 30 - 70 of survivors will recover enough function to enable daily use of the arm These numbers clearly indicate that despite significant advances in the ability to rehabilitate stroke patients there is still a need for more effective methods
Traditional rehabilitative methods to improve arm function after stroke are often time-consuming and labor-intensive Only few of these methods induce slightly improved arm function and full recovery of arm function is often not achieved Recently studies have indicated that robotic training has promise for improving functional abilities among stroke survivors by enabling repetitive adaptive and intensive training and more accurate control of task complexity One type of robotic training that is particularly promising is error enhancement which utilizes the adaptive capabilities of the nervous system to improve motor function
Study Objectives To examine the change in the upper limb function among stroke patients undergoing error enhancement treatment compared to a control group in the following domains
1 Motor Function Motor Assessment Scale-MAS Fugl-Meyer Assessment
2 Speed Box and Blocks Assessment
3 Tone and Spasticity Modified Ashworth Scale
Methods Participants 40 stroke patients with hemiparesis recruited 21-60 days following the Cerebrovascular accident event
Recruitment Electronic medical records of newly hospitalized patients will be screened to identify potential study participants Participation will be offered to each patient who meets the study inclusion criteria After obtaining informed consent an intake session will take place for both participant screening and evaluation conducted by a qualified occupational therapist Patients who successfully pass the intake screening session will undergo randomization to one of the two study arms
Another occupational therapist will be conducting the treatment sessions Patients in the intervention arm will undergo training sessions on the Dextreme robot device while the error enhancement mechanism is switched on while the patients in the control arm will undergo similar sessions with the mechanism switched off A second patient assessment will be conducted within 96 hours following the last treatment session by an allocation-blinded occupational therapist
Traditional rehabilitative methods to improve arm function after stroke are often time-consuming and labor-intensive Only few of these methods induce slightly improved arm function and full recovery of arm function is often not achieved Recently studies have indicated that robotic training has promise for improving functional abilities among stroke survivors by enabling repetitive adaptive and intensive training and more accurate control of task complexity One type of robotic training that is particularly promising is error enhancement which utilizes the adaptive capabilities of the nervous system to improve motor function
Study Objectives To examine the change in the upper limb function among stroke patients undergoing error enhancement treatment compared to a control group in the following domains
1 Motor Function Motor Assessment Scale-MAS Fugl-Meyer Assessment
2 Speed Box and Blocks Assessment
3 Tone and Spasticity Modified Ashworth Scale
Methods Participants 40 stroke patients with hemiparesis recruited 21-60 days following the Cerebrovascular accident event
Recruitment Electronic medical records of newly hospitalized patients will be screened to identify potential study participants Participation will be offered to each patient who meets the study inclusion criteria After obtaining informed consent an intake session will take place for both participant screening and evaluation conducted by a qualified occupational therapist Patients who successfully pass the intake screening session will undergo randomization to one of the two study arms
Another occupational therapist will be conducting the treatment sessions Patients in the intervention arm will undergo training sessions on the Dextreme robot device while the error enhancement mechanism is switched on while the patients in the control arm will undergo similar sessions with the mechanism switched off A second patient assessment will be conducted within 96 hours following the last treatment session by an allocation-blinded occupational therapist
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?:
False
Is an FDA AA801 Violation?:
None