Effects of Ritalin on Postural Stability of Old Adults

Postural Imbalance Clinical Trial

Official title:

Effects of Methylphenidate on Postural Stability of Old Adults Under Single and Dual Task Conditions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817960
• Other study ID #: SOR476508CTIL
• Secondary ID: MZ4765
• Status: Completed
• Phase: N/A
• First received: January 6, 2009
• Last updated: June 19, 2012
• Start date: July 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2008
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age 65 years old and older

• independent elderly adults

• do not suffer from balance prblems

• minimental score 24 and above

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postural Imbalance

Intervention

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

Locations

Country	Name	City	State
Israel	SorokaUMC	Beer-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postural sway measures		Time 1: pre test` and hour later time 2: post testinng proceedure	No