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Hand Grasping Techniques on Eliciting the Grasp Reflex in Patients With Dementia (GRASP)

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
palmar grasp without dorsal stimulation
standard palmar grasp test with dorsal stimulation
Sponsored by
Rowan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia focused on measuring dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Ability to sign informed consent or have a surrogate present to sign the consent
  2. Age 18 or above
  3. Patients are diagnosed with dementia, Alzheimer's disease, or frontal lobe dysfunction
  4. Medications are to remain stable during the course of the study except for emergency modifications.

Exclusion Criteria:

  1. Inability to obtain informed consent from patient or surrogate
  2. Unable to follow commands.
  3. Physical restrictions (i.e. spasticity of hands/arms, upper extremity amputation)
  4. Other comorbidities such as muscular diseases, hepatic encephalopathy, renal failure, down syndrome, NPH, depression, and cerebral palsy.

Sites / Locations

  • Rowan University School of Osteopathic Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Standard

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 5, 2016
Last Updated
October 24, 2019
Sponsor
Rowan University
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1. Study Identification

Unique Protocol Identification Number
NCT02925273
Brief Title
Hand Grasping Techniques on Eliciting the Grasp Reflex in Patients With Dementia
Acronym
GRASP
Official Title
The Effect of Hand Grasping Techniques on Eliciting the Grasp Reflex in Patients With Dementia or Suspected Frontal Lobe Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
May 23, 2018 (Actual)
Study Completion Date
May 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rowan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
dementia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
palmar grasp without dorsal stimulation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
standard palmar grasp test with dorsal stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Grasp response
Description
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
Time Frame
six months
Secondary Outcome Measure Information:
Title
Frontal Lobe release- Glabellar Response
Description
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.
Time Frame
six months
Title
Frontal lobe release- Palmomental Response
Description
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.
Time Frame
six months
Title
Frontal lobe release- Snout Response
Description
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.
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Barone, DO
Organizational Affiliation
Rowan University School of Osteopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rowan University School of Osteopathic Medicine
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Hand Grasping Techniques on Eliciting the Grasp Reflex in Patients With Dementia

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