NCT00817960

Brief Summary

Experimental design overview The proposed project is a prospective experimental study design. independent old adults(age 65 years old and older) who do not suffer from balance problems willing to participate in the study will be tested with well-established measuring techniques of Balance control before and 2 hours after taking of Methylphenidate (Ritalin) in the movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins \& De Luca, 1993). For each of the conditions (before and 1 hour after the use of Ritalin) in three task conditions single task; dual task (concentrating and identifying specific music); and just Listening to a relaxing music. Participants will be required to stand on the platform 10 times for 30 s. For each trial, they will be instructed to sway as little as possible.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

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

First Submitted

Initial submission to the registry

January 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
2.5 years until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 20, 2012

Status Verified

December 1, 2008

Enrollment Period

6 months

First QC Date

January 6, 2009

Last Update Submit

June 19, 2012

Conditions

Keywords

Dual taskingPostural ControlMethylphenidate (Ritalin)old adults

Outcome Measures

Primary Outcomes (1)

  • Postural sway measures

    Time 1: pre test' and hour later time 2: post testinng proceedure

Study Arms (1)

Methylphenidate

EXPERIMENTAL
Drug: Methylphenidate

Interventions

The effect of ritalin on postural stability of old adults (65 years old and over) will be measured using RCT study design

Methylphenidate

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 years old and older
  • independent elderly adults
  • do not suffer from balance prblems
  • minimental score 24 and above

You may not qualify if:

  • old adults who suffer from neurological disease or stroke
  • old adults who suffer from psychiatric state
  • old adults who suffer from orthopedic condition (1/2 a year after a fracture in the lower limb)
  • old adults who suffer from heart conditions
  • old adults who suffer from blindness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SorokaUMC

Beersheba, Israel, 84105, Israel

Location

MeSH Terms

Interventions

Methylphenidate

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Itshak Melzer, PhD

    Ben-gurion University of the Negev, Beer-Sheva, Israel

    PRINCIPAL INVESTIGATOR
  • Zmir Shorer, m

    Soroka University Medical Centar

    STUDY CHAIR
  • Yan Press, MD

    Soroka University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 7, 2009

Study Start

July 1, 2011

Primary Completion

January 1, 2012

Study Completion

June 1, 2012

Last Updated

June 20, 2012

Record last verified: 2008-12

Locations