NCT00061230

Brief Summary

This study will examine the effectiveness of relaxation training for providing pain relief and improving physical and psychological functioning in youth with physical disabilities due to cerebral palsy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2003

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 2003

First QC Date

May 22, 2003

Last Update Submit

June 23, 2005

Conditions

Cerebral Palsy

Keywords

Relaxation training

Interventions

biofeedback-monitored relaxation trainingBEHAVIORAL

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Cerebral palsy
  • Referred by the study physician
  • Chronic cerebral palsy-related pain for at least 3 months prior to study entry. The pain needs to have an average daily occurrence of 3 on a 0 to 10 scale, where 0 is no pain and 10 is extreme pain.
  • Primary language is English

You may not qualify if:

  • Acute painful conditions
  • Cognitive impairment as determined by a score \< 12 on the modified Mini-Mental Status Exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Joyce M. Engel, Ph.D.

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 22, 2003

First Posted

May 23, 2003

Study Start

March 1, 2003

Study Completion

March 1, 2006

Last Updated

June 24, 2005

Record last verified: 2003-04

Locations

US(1)