Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-13 @ 7:53 AM
Study NCT ID:
NCT02459951
Status:
COMPLETED
Last Update Posted:
2019-07-18
First Post:
2015-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Holding Function of the Hemiplegic Hand
Sponsor:
Nathaniel Mayer
Organization:
Study Overview
Official Title:
Improving Holding Function of the Hemiplegic Hand With Chemodenervation
Status:
COMPLETED
Status Verified Date:
2019-07
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:
Relevant to patients with spastic hemiparesis in the hand and upper limb, this pilot project proposes to measure the effects of botulinum toxin injections through observation of performance on a functional task known as 'hand as a holder'. This task requires the person with hemiplegia to insert an object into the affected hand and hold it independently.
The project aims to demonstrate reliability and validity of a digital video method that will be used to measure 'insertion time'. It also aims to establish initial statistical support for improved object insertion time into the hemiplegic clenched fist after Botox A injections.
The project aims to demonstrate reliability and validity of a digital video method that will be used to measure 'insertion time'. It also aims to establish initial statistical support for improved object insertion time into the hemiplegic clenched fist after Botox A injections.
Detailed Description:
Holding is an everyday hand function, objects entering the hand radially, frontally, ulnarly or in-between the finger spaces. After a stroke, the hand of a person with hemiplegia typically lacks voluntary finger extension that opens the hand. Simultaneously, the hand is also subjected to involuntary contraction of finger flexor muscles that close the hand, resulting in clenched fist and thumb-in-palm deformities. Despite these typical hemiplegic configurations, persons with stroke may be able to insert an object into the hand by wiggling and pushing it into the hemiplegic hand with their uninvolved hand, though struggle is often present and failure is frequent. In the hemiplegic patient, a common driver of clenched fist and thumb-in-palm configurations is excessive involuntary neural activation of finger and thumb flexors, compounded by impaired or absent voluntary finger extension. Excessive finger and thumb flexor contractions have been variously ascribed to involuntary phenomena such as spasticity, spastic dystonia, co-contraction, associated reactions and others. For the investigators purpose here, these involuntary phenomena generate contractile tension in hand and thumb muscles that choke the hand's potential to function as a holder of objects as described above.
The underlying rationale of this project is to examine whether hemiplegic 'hand as a holder' function can be improved by weakening involuntary muscle contractions that generate clenched fist and thumb in palm using the neuromuscular blocking properties of Botox A. The investigators hypothesize that 'hand as a holder' function will improve after chemodenervation of relevant finger, thumb and wrist muscles selected by clinical examination.
Nine subjects will be enrolled. Baseline observations will be made on two occasions prior to Botox A injection and outcomes measured four weeks later. A digital video method will be used to measure 'insertion time' at all-time points. Given the importance of the relationship between "statistically significant" research results and "clinically significant", person-oriented, functional improvement, the investigators also hypothesize that experienced clinicians will independently rate the performance of object insertion into the clenched fist as globally better after chemodenervation.
The underlying rationale of this project is to examine whether hemiplegic 'hand as a holder' function can be improved by weakening involuntary muscle contractions that generate clenched fist and thumb in palm using the neuromuscular blocking properties of Botox A. The investigators hypothesize that 'hand as a holder' function will improve after chemodenervation of relevant finger, thumb and wrist muscles selected by clinical examination.
Nine subjects will be enrolled. Baseline observations will be made on two occasions prior to Botox A injection and outcomes measured four weeks later. A digital video method will be used to measure 'insertion time' at all-time points. Given the importance of the relationship between "statistically significant" research results and "clinically significant", person-oriented, functional improvement, the investigators also hypothesize that experienced clinicians will independently rate the performance of object insertion into the clenched fist as globally better after chemodenervation.
Study Oversight
Has Oversight DMC:
False
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?: