DementiaGRASPNCT02925273
Hand Grasping Techniques on Eliciting the Grasp Reflex in Patients With Dementia
A study testing palmar grasp without dorsal stimulation and standard palmar grasp test with dorsal stimulation in people with Dementia, run by Rowan University at 1 site in United States.
Trial summary
In this study, the investigators will determine the difference between the two techniques used to elicit the grasp response in patients with frontal lobe dysfunction, primarily in dementia patients versus control patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- palmar grasp without dorsal stimulation and standard palmar grasp test with dorsal stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 23 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to sign informed consent or have a surrogate present to sign the consent
- Age 18 or above
- Patients are diagnosed with dementia, Alzheimer's disease, or frontal lobe dysfunction
- Medications are to remain stable during the course of the study except for emergency modifications.
Who cannot join
- Inability to obtain informed consent from patient or surrogate
- Unable to follow commands.
- Physical restrictions (i.e. spasticity of hands/arms, upper extremity amputation)
- Other comorbidities such as muscular diseases, hepatic encephalopathy, renal failure, down syndrome, NPH, depression, and cerebral palsy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rowan University School of Osteopathic Medicine
Stratford, New Jersey, 08084
About this study
Official title: The Effect of Hand Grasping Techniques on Eliciting the Grasp Reflex in Patients With Dementia or Suspected Frontal Lobe Dysfunction
In this study, the investigators will determine the difference between the two techniques used to elicit the grasp response in patients with frontal lobe dysfunction, primarily in dementia patients versus control patients.
Read the detailed description
The goal of this project is to determine the optimal technique to elicit the grasping response in patients with dementia or suspected frontal lobe dysfunction. The proposed study is to perform two techniques to elicit grasp response in patients with dementia or suspected frontal lobe dysfunction and observe the presence or absence of the response and prominence of the response on a proposed rating scale. Future goals will be aimed at aiding clinicians in refining their clinical techniques to be more sensitive for diagnosing frontal lobe dysfunctions.
- Conditions
- Dementia
- Being tested
- palmar grasp without dorsal stimulation, standard palmar grasp test with dorsal stimulation
- Keywords
- dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palmar grasp without dorsal stimulationOther
The patient will then be asked to keep the arms at 90 degrees and the researcher will slightly stroke palm and fingers of both hands of the patient simultaneously. After completion of each technique, the presence or absence of the response will be noted. In addition, the prominence of the response on the rating scale will be obtained as explained below.
The scaling of the grasp response is as followed:
- Flexion at the distal interphalangeal joint of the hand
- Flexion at the proximal interphalangeal joint of the hand
- Flexion at the metacarpal-phalangeal joint of the hand
standard palmar grasp test with dorsal stimulationOther
The patient will be asked to put their arms at 90 degrees and the researcher will hold one hand at the wrist and dorsum of the palm and lightly stroke the palm and fingers. The patient will be instructed to relax hands and not hold on while doing the grasp and see if the response persists. The same technique will be repeated for the patient's other hand.
| Study group | Role | What they receive |
|---|---|---|
| Standard | Other | Prospective, grasp techniques will be compared in each patient from the experimental group using a palmar grasp without dorsal stimulation and a standard palmar grasp test with dorsal stimulation on the same patient as the control group Receives: Other: palmar grasp without dorsal stimulation; Other: standard palmar grasp test with dorsal stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grasp response
The primary objective of the study will be to determine if a change in the performance of the grasp response will lead to a change in the way the response is elicited. The prominence of the grasp response will be scored on a rating scale
Measured: six months
Secondary outcomes (3)
Frontal Lobe release- Glabellar Response
The secondary objective during this study will be to determine if other frontal release signs are present in study participants. The glabellar response will be tested.
Measured: six months
Frontal lobe release- Palmomental Response
The secondary objective during this study will be to determine if other frontal release signs are present in study participants. The palmomental response will be tested.
Measured: six months
Frontal lobe release- Snout Response
The secondary objective during this study will be to determine if other frontal release signs are present in study participants. The snout response will be tested.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startJul 2016
- Primary completion23 May 2018
- Study completion23 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Fedor, Rowan University
- Investigators
- Donald Barone, DO, Principal investigator, Rowan University School of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925273
- Sponsor's protocol ID
- GRASP
- Acronym
- GRASP
- Status last verified
- Oct 2019
- First submitted
- 5 Aug 2016
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hand Grasping Techniques on Eliciting the Grasp Reflex in Patients With Dementia or Suspected Frontal Lobe Dysfunction
- ClinicalTrials.gov ID
- NCT02925273
- Acronym / sponsor ID
- GRASP / GRASP
- Conditions
- Dementia
- Keywords
- dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 23 May 2018 (actual)
- Study completion
- 23 May 2018 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators will determine the difference between the two techniques used to elicit the grasp response in patients with frontal lobe dysfunction, primarily in dementia patients versus control patients.
Detailed description
The goal of this project is to determine the optimal technique to elicit the grasping response in patients with dementia or suspected frontal lobe dysfunction. The proposed study is to perform two techniques to elicit grasp response in patients with dementia or suspected frontal lobe dysfunction and observe the presence or absence of the response and prominence of the response on a proposed rating scale. Future goals will be aimed at aiding clinicians in refining their clinical techniques to be more sensitive for diagnosing frontal lobe dysfunctions.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard | Other | Other: palmar grasp without dorsal stimulation, Other: standard palmar grasp test with dorsal stimulationProspective, grasp techniques will be compared in each patient from the experimental group using a palmar grasp without dorsal stimulation and a standard palmar grasp test with dorsal stimulation on the same patient as the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to sign informed consent or have a surrogate present to sign the consent
- Age 18 or above
- Patients are diagnosed with dementia, Alzheimer's disease, or frontal lobe dysfunction
- Medications are to remain stable during the course of the study except for emergency modifications.
Key exclusion criteria (4 listed)
- Inability to obtain informed consent from patient or surrogate
- Unable to follow commands.
- Physical restrictions (i.e. spasticity of hands/arms, upper extremity amputation)
- Other comorbidities such as muscular diseases, hepatic encephalopathy, renal failure, down syndrome, NPH, depression, and cerebral palsy.
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 |
|---|---|---|
| palmar grasp without dorsal stimulationThe patient will then be asked to keep the arms at 90 degrees and the researcher will slightly stroke palm and fingers of both hands of the patient simultaneously. After completion of each technique, the presence or absence of the response will be noted. In addition, the prominence of the response on the rating scale will be obtained as explained below. The scaling of the grasp response is as followed: 1. Flexion at the distal interphalangeal joint of the hand 2. Flexion at the proximal interphalangeal joint of the hand 3. Flexion at the metacarpal-phalangeal joint of the hand | Other | Standard |
| standard palmar grasp test with dorsal stimulationThe patient will be asked to put their arms at 90 degrees and the researcher will hold one hand at the wrist and dorsum of the palm and lightly stroke the palm and fingers. The patient will be instructed to relax hands and not hold on while doing the grasp and see if the response persists. The same technique will be repeated for the patient's other hand. | Other | Standard |
Primary outcome
Grasp response
Time frame: six months
The primary objective of the study will be to determine if a change in the performance of the grasp response will lead to a change in the way the response is elicited. The prominence of the grasp response will be scored on a rating scale
3 secondary outcomes
Frontal Lobe release- Glabellar Response
Time frame: six months
Frontal lobe release- Palmomental Response
Time frame: six months
Frontal lobe release- Snout Response
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- 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.
Donald Barone, DO principal investigator
Rowan University School of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing palmar grasp without dorsal stimulation and standard palmar grasp test with dorsal stimulation in people with Dementia, run by Rowan University at 1 site in United States.
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 4 inclusion and 4 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 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Grasp response (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.