N/A
N=10
Improving Holding Function of the Hemiplegic Hand
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02459951 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Geometric Ratios of Log-transformed Transit Time — 1.19; 1.07; 0.79; 0.72 dimensionless ratio — p=.059
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- clenched fist (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Nathaniel Mayer
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Ratios of Log-transformed Transit Time |
1.19; 1.07; 0.79; 0.72; 0.66 | .059 |
| SECONDARY Fraction of Successful Holds for Each Evaluation Session |
.67; .51; .53 | — |
| SECONDARY Ratio of Successful Holds |
1.31; 1.26; .96 | — |
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.
Eligibility Criteria
Inclusion Criteria
- patients who are clinically appropriate for treatment of upper limb spasticity due to stroke with Botox A injections ;
- adults up to age 80, women must be post-menopausal or are medically unable to conceive (as determined from their medical records), men must be at least age 35
- documented anemic or hemorrhagic unilateral (right or left) hemiplegic stroke, with 1 year or more prior to enrollment
- able to understand verbal and visual instructions and demonstrations regarding the protocol
- a resting wrist angle equal to or less than 0
- spasticity is present in finger flexors and thumb coupled with marked voluntary paresis of finger extension (no finger has more than half range of active extension at any joint). By squeezing the examiner's finger, participants will have demonstrated, at least, some detectable voluntary contraction of finger flexors; impaired sensation is acceptable but participants must be aware that they are holding something, as tested clinically;
- at least two finger flexors with an Ashworth score = 3;
- moderate motor severity as defined by an upper limb Fugl-Meyer motor scores between 21-50
- normal joint capsule without contractures as determined by clinical exam; participant may have tightness/shortening of extrinsic finger flexors but composite extension of wrist and fingers comes to at least neutral (i.e. fingers and wrist can be brought to neutral position simultaneously).
Exclusion Criteria
- profound sensory loss/absent touch sensation
- known hypersensitivity/allergy to Botox A
- acute illness or unresolved medical/psychiatric conditions at time of assessment
- symptomatic lung disease and compromised respiratory status; muscle-weakening neurological disorders known to increase drug-related risk [e.g. amyotrophic lateral sclerosis (ALS), myasthenia gravis, Lambert-Eaton syndrome, or motor neuropathy]
- infection in the area where the study drug should be injected
- pregnancy or breast-feeding;
- participant had Botox injections less than 4 months previously
- clenched fist associated with tenodesis of an extended wrist i.e. resting position of wrist is > 0 degrees
Data sourced from ClinicalTrials.gov (NCT02459951). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.