StrokeNCT02459951
Improving Holding Function of the Hemiplegic Hand
An observational study of Stroke, run by Nathaniel Mayer.
Trial 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'. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- clenched fist
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to 30 Apr 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who are clinically appropriate for Botox A injection to treat upper limb spasticity due to stroke
Who may be able to join
- 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;
Show all 9Show fewer
- 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).
Who cannot join
- 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
About this study
Official title: Improving Holding Function of the Hemiplegic Hand With Chemodenervation
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- clenched fist
- Keywords
- Muscle Spasticity, Botox A, Upper limb hemiplegia
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clenched fistOther
Observation of performance on a standardized behavioral task pre- and post- administration of Botox A in the context of routine care. Clinical assessment and judgment will be used to determine dosing and which muscles contribute to the hand deformities of a given participant.
| Study group | Role | What they receive |
|---|---|---|
| clenched fist | Adult participants with upper limb hemiparesis secondary to stroke and greater than 12 months duration. Medical determination that .botulinum toxin injections are indicated for treatment of spasticity. Receives: Other: clenched fist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Ratios of Log-transformed Transit Time
Time (log-transformed) required for contralateral hand to insert a plastic cylinder successfully into the hemiplegic clenched fist AND assessed at Pre-injection baseline 2 and a Post-injection session expressed as a geometric mean ratio of these sessions. (Success is defined by a hold of 5 secs or more). Geometric mean ratios are calculated for each of 5 cylinder sizes (A-E)
Measured: days post-injection evaluation (mean 26 days; range 21-30 days)
Secondary outcomes (2)
Fraction of Successful Holds for Each Evaluation Session
fraction of successful holds for each evaluation session (Pre1, Pre2, and Post)
Measured: days between two baseline evaluations (mean 6; range 2-14) and days post-injection evaluation (mean 26; range 21-30)
Ratio of Successful Holds
ratio of successful holds post/pre1, post/pre2 or pre1/pre2
Measured: days between two baseline evaluations (mean 6; range 2-14) and days post-injection evaluation (mean 26; range 21-30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion31 Jan 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nathaniel Mayer
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor-investigator, Nathaniel Mayer, Albert Einstein Healthcare Network
- Investigators
- Nathaniel Mayer, MD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459951
- Sponsor's protocol ID
- 4729FBD
- Status last verified
- Jul 2019
- First submitted
- 14 May 2015
- Last updated
- 18 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mayer NH, Ferraro M, Pauloski-Hunt D, Chervoneva I. Capacity for Hand-as-a-Holder Function of the Spastic Combination Hand: A Proof-of-Concept Study. Am J Phys Med Rehabil. 2022 Mar 1;101(3):298-302. doi: 10.1097/PHM.0000000000001834.
PubMed 34173778
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Holding Function of the Hemiplegic Hand With Chemodenervation
- ClinicalTrials.gov ID
- NCT02459951
- Acronym / sponsor ID
- 4729FBD
- Conditions
- Stroke
- Keywords
- Muscle Spasticity, Botox A, Upper limb hemiplegia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nathaniel MayerUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jul 2015
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Posted 1 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clenched fist | – | Other: clenched fistAdult participants with upper limb hemiparesis secondary to stroke and greater than 12 months duration. Medical determination that .botulinum toxin injections are indicated for treatment of spasticity. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who are clinically appropriate for Botox A injection to treat upper limb spasticity due to stroke
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clenched fistObservation of performance on a standardized behavioral task pre- and post- administration of Botox A in the context of routine care. Clinical assessment and judgment will be used to determine dosing and which muscles contribute to the hand deformities of a given participant. | Other | clenched fist |
Primary outcome
Geometric Ratios of Log-transformed Transit Time
Time frame: days post-injection evaluation (mean 26 days; range 21-30 days)
Time (log-transformed) required for contralateral hand to insert a plastic cylinder successfully into the hemiplegic clenched fist AND assessed at Pre-injection baseline 2 and a Post-injection session expressed as a geometric mean ratio of these sessions. (Success is defined by a hold of 5 secs or more). Geometric mean ratios are calculated for each of 5 cylinder sizes (A-E)
2 secondary outcomes
Fraction of Successful Holds for Each Evaluation Session
Time frame: days between two baseline evaluations (mean 6; range 2-14) and days post-injection evaluation (mean 26; range 21-30)
Ratio of Successful Holds
Time frame: days between two baseline evaluations (mean 6; range 2-14) and days post-injection evaluation (mean 26; range 21-30)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34173778Mayer NH, Ferraro M, Pauloski-Hunt D, Chervoneva I. Capacity for Hand-as-a-Holder Function of the Spastic Combination Hand: A Proof-of-Concept Study. Am J Phys Med Rehabil. 2022 Mar 1;101(3):298-302. doi: 10.1097/PHM.0000000000001834.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel Mayer, MD principal investigator
Albert Einstein Healthcare Network
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Nathaniel Mayer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Ratios of Log-transformed Transit Time (time frame: days post-injection evaluation (mean 26 days; range 21-30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02459951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.