NCT02925273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2018

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

1.9 years

First QC Date

August 5, 2016

Last Update Submit

October 24, 2019

Conditions

Dementia

Keywords

dementia

Outcome Measures

Primary Outcomes (1)

  • 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

    six months

Secondary Outcomes (3)

  • Frontal Lobe release- Glabellar Response

    six months

  • Frontal lobe release- Palmomental Response

    six months

  • Frontal lobe release- Snout Response

    six months

Study Arms (1)

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

Other: palmar grasp without dorsal stimulationOther: standard palmar grasp test with dorsal stimulation

Interventions

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: 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

Standard
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.

Standard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rowan University School of Osteopathic Medicine

Stratford, New Jersey, 08084, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Donald Barone, DO

    Rowan University School of Osteopathic Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Manager

Study Record Dates

First Submitted

August 5, 2016

First Posted

October 5, 2016

Study Start

July 1, 2016

Primary Completion

May 23, 2018

Study Completion

May 23, 2018

Last Updated

October 28, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)