NCT00924261

Brief Summary

Based on their preliminary quantitative gait findings suggesting that limited passive hip extension range is a key functionally limiting impairment affecting gait, the investigators propose a supervised, specific stretching exercise with the aim to improve both peak hip extension and overall gait performance. While one goal is to demonstrate that reduced peak passive hip extension is a key, functionally significant, but reversible, impairment another is to improve our understanding of the relationship between impairment, functional limitation and gait ability.

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
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2007

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

February 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 4, 2009

Status Verified

September 1, 2009

Enrollment Period

2.3 years

First QC Date

June 16, 2009

Last Update Submit

September 3, 2009

Conditions

GaitFlexibility

Keywords

hipgaitwalkingfallsstretchingFlexibilityAged

Outcome Measures

Primary Outcomes (1)

  • Hip Extension

    10 weeks

Secondary Outcomes (1)

  • Hip Flexibility

    10 weeks

Study Arms (2)

Hip Stretching

EXPERIMENTAL

Kneeling Hip flexor stretch - 3 minutes a day, daily, for 10 weeks

Other: Hip Stretch

Shoulder Stretch

EXPERIMENTAL

Shoulder Stretch - 3 minutes daily for 10 weeks

Other: Shoulder Stretch

Interventions

Hip StretchOTHER

Hip flexor stretch daily for 3 min x 10 weeks

Also known as: Thomas Test, Hip flexibility
Hip Stretching
Shoulder StretchOTHER

Shoulder Adduction stretch - 3 minutes, daily, for 10 weeks

Also known as: Shoulder Horizontal Adduction Stretch
Shoulder Stretch

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Elderly Adult Subjects:
  • subjects aged 65 years and older will be recruited from the Charlottesville area.
  • After this initial health questionnaire screening, each participant will undergo a face-to-face history and physical examination screening.
  • Frail Elderly Subjects:
  • subjects aged 65 years and older who meet the criteria of not being able to function independently, which is considered to be frail, living within the greater Charlottesville area will be recruited for participation in the study.

You may not qualify if:

  • Healthy Elderly:
  • acute medical illness,
  • diagnosis or symptoms of unstable angina or congestive heart failure,
  • pulmonary diagnosis or symptoms of emphysema, chronic obstructive disease or asthma and shortness of breath as a result of pulmonary diagnosis brought about by walking on a flat surface,
  • advanced cancer,
  • neurologic diagnosis including Parkinson's Disease, stroke, brain injury, cerebellar disease, myelopathy, myopathy, peripheral neuropathy, or active radiculopathy,
  • major orthopedic diagnosis in the lower back, pelvis, or lower extremities, including hip or other fracture since the age of 50, fused joint, joint replacement, or amputation,
  • severe osteoarthritis or rheumatoid arthritis or active joint or musculoskeletal pain in the back or lower extremities occurring at rest or with walking,
  • severe osteoporosis with a history of a fragility fracture occurring in the past 12 months, and
  • regular use of an assistive device for walking.
  • physical signs of congestive heart failure,
  • muscle weakness (less than 4/5 manual muscle test strength in lower extremities or focal findings of 1/5 strength difference between sides or upper and lower extremities), absent knee extensor reflexes or positive Babinski responses,
  • corrected visual acuity worse than 20/100 or presence of a field defect,
  • poor mental state defined with a Mini-Mental Status Examination score less than or equal to 24/30,133
  • orthostatic hypotension (greater than 20mmHg decline in systolic blood pressure from supine to standing at one minute), and
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Medicine and Rehabilitation, University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Study Officials

  • Diedre C Kerrigan, MD, MS

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2009

First Posted

June 18, 2009

Study Start

February 1, 2007

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

September 4, 2009

Record last verified: 2009-09

Locations

US(1)