GaitNCT00924261
Age-Related Gait Changes and Hip Flexibility
A study testing Hip Stretch and Shoulder Stretch in people with Gait and Flexibility, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait, Flexibility
- What is being tested?
- Hip Stretch and Shoulder Stretch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Elderly Adult Subjects:
- 100 subjects aged 65 years and older will be recruited from the Charlottesville area.
- Participants will be asked to fill out a health questionnaire identical to that used for all preliminary studies. This questionnaire verifies that the participants meet the inclusion criteria for the proposed research project.
- After this initial health questionnaire screening, each participant will undergo a face-to-face history and physical examination screening.
- Frail Elderly Subjects:
- 100 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.
Who cannot join
- 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,
Show all 32Show fewer
- 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
- unilateral sensory deficit in lower extremities, bilateral sensory loss in stocking distribution, proprioception less than 75% correct in identifying great toe position, or vibration (from with a 128Hz tuning fork) perceived for less than 10 seconds at either the great toe or medial malleolus in either extremity.
- Frail Elderly (who do not Function Independently):
- are unable to walk independently (i.e., unable to walk without the assistance of another person), or
- have either an acute medical condition or a chronic underlying medical condition which would make it unfeasible or unsafe to participate.
- Regular use of an assistive device, such as a cane, for walking is not an exclusion criterion as long as:
- when using the device, the subject does not require the assistance of another person and
- the subject can walk without the assistive device (with supervisory, but not physical assistance if needed) for the length of the testing walkway, ten times (with rest periods between) at both his/her comfortable walking speed and at a faster walking speed.
- Based upon the questionnaire or medical history, the following specific exclusion criteria will be used:
- acute medical illness,
- symptoms of angina or dyspnea brought about by walking on a flat surface,
- hip or knee replacement surgery or hip fracture in the previous six months,
- advanced cancer and/or life expectancy of less than 12 months,
- dementia or other illness characterized by cognitive impairment.
- Based upon physical examination, subjects will be excluded if they have:
- physical signs of congestive heart failure,
- cognitive impairment defined as a Mini-Mental Status Examination score less than or equal to 24/30133 or
- orthostatic hypotension (greater than 20mm Hg decline in systolic blood pressure from supine to standing at one minute).
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Physical Medicine and Rehabilitation, University of Virginia
Charlottesville, Virginia, 22903
About this study
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.
Read the detailed description
- Test the hypothesis that both passive and dynamic hip extension during comfortable and fast walking speeds are reduced in the elderly groups compared to passive and dynamic peak hip extension in healthy young adults.
- Test the hypothesis, separately for each elderly group, controlling for co-factors, that there is greater change in step length in the treatment group compared to the control group, after controlling for co-variates. We also expect greater changes in dynamic hip peak extension, a reduction in anterior pelvic tilt, improvement in age-related reductions in peak ankle plantar flexion and ankle power generation, and in dynamic CoM-CoP moment arm during both comfortable and fast walking, and an increase in comfortable walking speed.
- Test the hypothesis separately for the frail elderly group who cannot independently perform IADL only, controlling for co-factors, that there is a greater change in secondary, non quantitative gait-parameters of the Timed Get Up and Go Test, Activities of Daily Living, Instrumental ADL function, fear of falling and number of falls during 6 months following intervention.
- Test the hypothesis that the created forward dynamic model can accurately predict in individual subjects, the actual effect of an increase in passive peak hip extension on dynamic peak hip extension, anterior pelvic tilt, peak ankle plantar flexion and step length.
- Conditions
- Gait, Flexibility
- Being tested
- Hip Stretch, Shoulder Stretch
- Keywords
- hip, gait, walking, falls, stretching, Flexibility, Aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip StretchOther
Also called Thomas Test, Hip flexibility
Hip flexor stretch daily for 3 min x 10 weeks
Shoulder StretchOther
Also called Shoulder Horizontal Adduction Stretch
Shoulder Adduction stretch - 3 minutes, daily, for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hip Stretching | Experimental | Kneeling Hip flexor stretch - 3 minutes a day, daily, for 10 weeks Receives: Other: Hip Stretch |
| Shoulder Stretch | Experimental | Shoulder Stretch - 3 minutes daily for 10 weeks Receives: Other: Shoulder Stretch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Extension
Measured: 10 weeks
Secondary outcomes (1)
Hip Flexibility
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startFeb 2007
- Primary completionJun 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GaitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Diedre C Kerrigan, MD, MS, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924261
- Sponsor's protocol ID
- 10101
- Other IDs
- 5R01AG27192-3, 5R01AG027192
- Status last verified
- Sep 2009
- First submitted
- 16 Jun 2009
- Last updated
- 4 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Related Gait Changes and Hip Flexibility
- ClinicalTrials.gov ID
- NCT00924261
- Acronym / sponsor ID
- 10101
- Conditions
- Gait, Flexibility
- Keywords
- hip, gait, walking, falls, stretching, Flexibility, Aged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Feb 2007
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Test the hypothesis that both passive and dynamic hip extension during comfortable and fast walking speeds are reduced in the elderly groups compared to passive and dynamic peak hip extension in healthy young adults.
- Test the hypothesis, separately for each elderly group, controlling for co-factors, that there is greater change in step length in the treatment group compared to the control group, after controlling for co-variates. We also expect greater changes in dynamic hip peak extension, a reduction in anterior pelvic tilt, improvement in age-related reductions in peak ankle plantar flexion and ankle power generation, and in dynamic CoM-CoP moment arm during both comfortable and fast walking, and an increase in comfortable walking speed.
- Test the hypothesis separately for the frail elderly group who cannot independently perform IADL only, controlling for co-factors, that there is a greater change in secondary, non quantitative gait-parameters of the Timed Get Up and Go Test, Activities of Daily Living, Instrumental ADL function, fear of falling and number of falls during 6 months following intervention.
- Test the hypothesis that the created forward dynamic model can accurately predict in individual subjects, the actual effect of an increase in passive peak hip extension on dynamic peak hip extension, anterior pelvic tilt, peak ankle plantar flexion and step length.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip Stretching | Experimental | Other: Hip StretchKneeling Hip flexor stretch - 3 minutes a day, daily, for 10 weeks |
| Shoulder Stretch | Experimental | Other: Shoulder StretchShoulder Stretch - 3 minutes daily for 10 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 100 subjects aged 65 years and older will be recruited from the Charlottesville area.
- Participants will be asked to fill out a health questionnaire identical to that used for all preliminary studies. This questionnaire verifies that the participants meet the inclusion criteria for the proposed research project.
- After this initial health questionnaire screening, each participant will undergo a face-to-face history and physical examination screening.
- 100 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.
Key exclusion criteria (32 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip StretchAlso: Thomas Test, Hip flexibilityHip flexor stretch daily for 3 min x 10 weeks | Other | Hip Stretching |
| Shoulder StretchAlso: Shoulder Horizontal Adduction StretchShoulder Adduction stretch - 3 minutes, daily, for 10 weeks | Other | Shoulder Stretch |
Primary outcome
Hip Extension
Time frame: 10 weeks
1 secondary outcome
Hip Flexibility
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2009.
Related trials for Gait
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Recruiting
Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
Parkinson Disease, Freezing of Gait
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
Not yet recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
Enrolling by invitation
AI-Guided Multi-Electrode Transcutaneous Spinal Cord Stimulation for Gait Rehabilitation in People With Spinal Cord Injury or Stroke
Spinal Cord Injuries (SCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diedre C Kerrigan, MD, MS principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip Stretch and Shoulder Stretch in people with Gait and Flexibility, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip Extension (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2009.