Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489580
Status:
COMPLETED
Last Update Posted:
2007-07-25
First Post:
2007-06-20
Brief Title:
A Pilot Study Investigating the Feasibility of the Saebo Arm Training Program on an Inpatient Population
Sponsor:
Kessler Foundation
Organization:
Kessler Foundation
Study Overview
Official Title:
A Pilot Study Investigating the Feasibility of Using a Functional Tone Management FTM Arm Training Program With the SaeboFlex Dynamic Hand Orthosis on an Inpatient Population
Status:
COMPLETED
Status Verified Date:
2007-07
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:
Study Objectives
1 To document the safe and effective application of the FTM Arm Training Program using the SaeboFlex to an inpatient post stroke rehabilitation population
2 To compare functional improvements in hand and UE use achieved with the FTM program as compared to generally applied therapeutic treatment approaches
3 To develop recommendations for an inpatient retraining protocol that could then be evaluated in a multi-center trial
4 To document the retention of UE and hand improvements after SaeboFlex training is discontinued as well as the carry over of these gains into daily function after therapy has been discontinued
1 To document the safe and effective application of the FTM Arm Training Program using the SaeboFlex to an inpatient post stroke rehabilitation population
2 To compare functional improvements in hand and UE use achieved with the FTM program as compared to generally applied therapeutic treatment approaches
3 To develop recommendations for an inpatient retraining protocol that could then be evaluated in a multi-center trial
4 To document the retention of UE and hand improvements after SaeboFlex training is discontinued as well as the carry over of these gains into daily function after therapy has been discontinued
Detailed Description:
Therapeutic interventions for the recovery of hand function after a neurological injury have historically been very limited A significant body of research now supports the use of an upper extremity retraining approach for functional recovery after neurological injury Few therapeutic approaches offer any intervention specifically focused on grasp and release retraining In an effort to address this deficit the SaeboFlex dynamic hand orthosis was developed by occupational therapists The FTM Arm Training Program has been safely used by hundreds of occupational and physical therapists on over one thousand patients in outpatient neurological rehabilitation over the past two years It is currently an accepted modality of treatment for the management of hand paresis in the acquired brain injury population During that time two factors other than the severity of the initial injury were identified as having a significant affect on the outcomes achieved in treatment They are learned non-use and soft tissue shortening of the finger flexors All treatment delivered to the subjects that partake in this study will be clinical care and the only research component of this study will be the assessment of outcomes The purpose of this study is to explore the proper treatment dosage and treatment protocol for the application of the FTM Program to the inpatient post stroke rehabilitation population Additionally information on functional outcome measures will be collected and compared to a matched control group that undergoes the standard therapeutic protocol
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