ProprioceptionNCT00100919
Sensing of Leg Position and Movement
An observational study of Proprioception, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will collect information on how people sense leg position and movement. The findings may help scientists develop better ways to evaluate and treat joint problems. Healthy adult volunteers between 21 and 40 years of age may be eligible for the study. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Proprioception
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2005to 6 Jul 2010
- Phase
- Observational
- 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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- This study will include healthy males and females between 21 and 40 years of age. This age range is scientifically justified as both the CNS and musculoskeletal system are not fully matured until adulthood while lower extremity proprioception is reported to decrease with older subjects. For this project the term healthy is defined as a lack of systemic disease that alters ability of subjects to participate in activities of their choice. In addition, healthy means no current pathology where there is any possibility of damage to muscle, ligament or cartilage in the lower extremity.
Who cannot join
- Subjects with a history of lower extremity musculoskeletal injury, which can alter peripheral feedback from cutaneous joint or muscle mechanoreceptors, will be excluded from this study. This includes a recent history of chronic or severe lower extremity injuries such as recent surgery, trauma, degenerative joint changes, which could influence performance in this study. Examples of exclusions include ankle sprains and patella dislocations and subjects will be excluded if they have experienced these injuries within the last six months. Multiple (greater than 3) injuries, such as those described, would warrant exclusion as this could be an indicator of impaired sensation or long term deficit. The presence of local pain or the presence of an impaired sensation, indicating possible CNS dysfunction will also exclude subjects from this study. Subjects with pain will be identified the screening form while subjects with impaired sensation, indicating CNS dysfunction, will be identified by Part 2, or the physical examination of the screening form. This screening form will also evaluate general muscle strength, range of motion, sensation and the joint integrity. This pilot study will use a total of thirty subjects. Subjects will also be screened for excessive hamstring tightness, as the position described above could produce some discomfort with prolonged subject positioning.
- This investigation is intended to develop methodology and obtain pilot data regarding the existence of coupled proprioception in mature healthy adults. Therefore, subjects below the age of 21 are excluded, as a developing musculoskeletal and central nervous system could impact the outcome of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Coupled Joint Proprioception and Multi-Joint Movement in the Lower Extremity: A Pilot Study
This study will collect information on how people sense leg position and movement. The findings may help scientists develop better ways to evaluate and treat joint problems.
Healthy adult volunteers between 21 and 40 years of age may be eligible for the study. Candidates are screened with a brief questionnaire and examination to determine their strength, flexibility, and sensation.
Read more
Participants sit on a specially designed chair, with their foot and leg placed in a custom-made apparatus that controls knee and ankle movements. The skin is marked to indicate the area of interest for ultrasound assessment of muscle. Subjects respond to joint position changes for several trials. The procedure takes a maximum of 2.5 hours to complete.
...
Read the detailed description
Proprioception can be described as afferent information typically arising from peripheral mechanoreceptors that contribute to postural control, joint stability and conscious sensation of movement. Sensation of movement can be further divided into joint position sense (JPS) and the detection of passive movement sense (DPMS). Collectively, these two sensory modalities are commonly referred to as joint kinesthesia. Joint kinesthesia appears dependent on specific joint anatomical structure, suggesting different levels of acuity among various joints. However, whole limb accuracy appears to be greater than summed error across multiple joints of an extremity. Some suggest that it is only JPS errors greater than 3 degrees that have any functional significance on gait. However, the authors' calculations of position error on gait neglect JPS errors from the ankle and hip, which could also severely influence whole limb position sense, impacting gait. We believe that the central nervous system (CNS) links together afferent proprioceptive feedback from multiple joints of a limb segment to reduce kinesthetic error across a whole limb. The redundancy of the afferent information can be used as an "error check" to improve proprioceptive feedback in order to maintain function. We have used the term Coupled Joint Proprioception (CJP) in order to describe this phenomenon.
To better understand the relationship between CJP and human function, we would have to isolate movement at two adjacent joints, while controlling bi-articular muscle length, to determine its influence on single joint kinesthesia. Bi-articular muscles provide a mechanical linkage within a limb to transfer forces. Afferent information from bi-articular muscles in particular could provide a context with which proprioceptive information from other structures (single joint muscles, joint or cutaneous receptors) can maintain or enhance proprioception within a limb. The redundant information, provided by the two-joint muscles, is the basis on which we describe CJP.
The overall objective of this non-invasive pilot study is to establish the methodology necessary to test the influence of CJP on knee joint kinesthesia and proprioceptive capabilities. The primary goal is to establish two experimental conditions in which similar motions of simultaneous knee joint extension and ankle joint plantar flexion result in shortening and lengthening of all gastrocnemius muscle fibers. Following establishment of these conditions, the second goal is to develop and evaluate novel methods for studying the influence of CJP on the detection of passive movement and joint position sense at the knee joint. The information from this pilot data will also help determine the total number of subjects required to undertake a larger clinical investigation of the CJP phenomenon.
It is important to study CJP, as proprioception is typically measured clinically at a single joint in human subjects. Human function usually incorporates multiple joints, suggesting that CJP, measured across two joints, could be more representative of human proprioceptive function. Therefore, CJP would provide an avenue to better study the influence of proprioceptive feedback on human function such as walking. This is especially important because maintaining proprioceptive feedback while walking may minimize falls in patients who are at risk due to lower extremity injuries or pathologies.
- Conditions
- Proprioception
- Keywords
- Kinesithesia, Sensorimotor Function, Somatosensory, Muscle Spindles, Sensory Feedback, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2005 (estimated)
- Study start4 Jan 2005
- Study completion6 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ProprioceptionStudies 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
- Observational
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100919
- Sponsor's protocol ID
- 050042
- Other IDs
- 05-CC-0042
- Status last verified
- 6 Jul 2010
- First submitted
- 6 Jan 2005
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Barrack RL, Skinner HB, Brunet ME, Haddad RJ Jr. Functional performance of the knee after intraarticular anesthesia. Am J Sports Med. 1983 Jul-Aug;11(4):258-61. doi: 10.1177/036354658301100414.
PubMed 6614298Barrack RL, Skinner HB, Brunet ME, Cook SD. Joint kinesthesia in the highly trained knee. J Sports Med Phys Fitness. 1984 Mar;24(1):18-20. No abstract available.
PubMed 6471834Barrack RL, Skinner HB, Cook SD. Proprioception of the knee joint. Paradoxical effect of training. Am J Phys Med. 1984 Aug;63(4):175-81.
PubMed 6465302
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coupled Joint Proprioception and Multi-Joint Movement in the Lower Extremity: A Pilot Study
- ClinicalTrials.gov ID
- NCT00100919
- Acronym / sponsor ID
- 050042
- Conditions
- Proprioception
- Keywords
- Kinesithesia, Sensorimotor Function, Somatosensory, Muscle Spindles, Sensory Feedback, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 4 Jan 2005
- Study completion
- 6 Jul 2010
- First posted
- 7 Jan 2005 (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.
This study will collect information on how people sense leg position and movement. The findings may help scientists develop better ways to evaluate and treat joint problems.
Healthy adult volunteers between 21 and 40 years of age may be eligible for the study. Candidates are screened with a brief questionnaire and examination to determine their strength, flexibility, and sensation.
Participants sit on a specially designed chair, with their foot and leg placed in a custom-made apparatus that controls knee and ankle movements. The skin is marked to indicate the area of interest for ultrasound assessment of muscle. Subjects respond to joint position changes for several trials. The procedure takes a maximum of 2.5 hours to complete.
...
Detailed description
Proprioception can be described as afferent information typically arising from peripheral mechanoreceptors that contribute to postural control, joint stability and conscious sensation of movement. Sensation of movement can be further divided into joint position sense (JPS) and the detection of passive movement sense (DPMS). Collectively, these two sensory modalities are commonly referred to as joint kinesthesia. Joint kinesthesia appears dependent on specific joint anatomical structure, suggesting different levels of acuity among various joints. However, whole limb accuracy appears to be greater than summed error across multiple joints of an extremity. Some suggest that it is only JPS errors greater than 3 degrees that have any functional significance on gait. However, the authors' calculations of position error on gait neglect JPS errors from the ankle and hip, which could also severely influence whole limb position sense, impacting gait. We believe that the central nervous system (CNS) links together afferent proprioceptive feedback from multiple joints of a limb segment to reduce kinesthetic error across a whole limb. The redundancy of the afferent information can be used as an "error check" to improve proprioceptive feedback in order to maintain function. We have used the term Coupled Joint Proprioception (CJP) in order to describe this phenomenon.
To better understand the relationship between CJP and human function, we would have to isolate movement at two adjacent joints, while controlling bi-articular muscle length, to determine its influence on single joint kinesthesia. Bi-articular muscles provide a mechanical linkage within a limb to transfer forces. Afferent information from bi-articular muscles in particular could provide a context with which proprioceptive information from other structures (single joint muscles, joint or cutaneous receptors) can maintain or enhance proprioception within a limb. The redundant information, provided by the two-joint muscles, is the basis on which we describe CJP.
The overall objective of this non-invasive pilot study is to establish the methodology necessary to test the influence of CJP on knee joint kinesthesia and proprioceptive capabilities. The primary goal is to establish two experimental conditions in which similar motions of simultaneous knee joint extension and ankle joint plantar flexion result in shortening and lengthening of all gastrocnemius muscle fibers. Following establishment of these conditions, the second goal is to develop and evaluate novel methods for studying the influence of CJP on the detection of passive movement and joint position sense at the knee joint. The information from this pilot data will also help determine the total number of subjects required to undertake a larger clinical investigation of the CJP phenomenon.
It is important to study CJP, as proprioception is typically measured clinically at a single joint in human subjects. Human function usually incorporates multiple joints, suggesting that CJP, measured across two joints, could be more representative of human proprioceptive function. Therefore, CJP would provide an avenue to better study the influence of proprioceptive feedback on human function such as walking. This is especially important because maintaining proprioceptive feedback while walking may minimize falls in patients who are at risk due to lower extremity injuries or pathologies.
Study design
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- This study will include healthy males and females between 21 and 40 years of age. This age range is scientifically justified as both the CNS and musculoskeletal system are not fully matured until adulthood while lower extremity proprioception is reported to decrease with older subjects. For this project the term healthy is defined as a lack of systemic disease that alters ability of subjects to participate in activities of their choice. In addition, healthy means no current pathology where there is any possibility of damage to muscle, ligament or cartilage in the lower extremity.
Key exclusion criteria (2 listed)
- Subjects with a history of lower extremity musculoskeletal injury, which can alter peripheral feedback from cutaneous joint or muscle mechanoreceptors, will be excluded from this study. This includes a recent history of chronic or severe lower extremity injuries such as recent surgery, trauma, degenerative joint changes, which could influence performance in this study. Examples of exclusions include ankle sprains and patella dislocations and subjects will be excluded if they have experienced these injuries within the last six months. Multiple (greater than 3) injuries, such as those described, would warrant exclusion as this could be an indicator of impaired sensation or long term deficit. The presence of local pain or the presence of an impaired sensation, indicating possible CNS dysfunction will also exclude subjects from this study. Subjects with pain will be identified the screening form while subjects with impaired sensation, indicating CNS dysfunction, will be identified by Part 2, or the physical examination of the screening form. This screening form will also evaluate general muscle strength, range of motion, sensation and the joint integrity. This pilot study will use a total of thirty subjects. Subjects will also be screened for excessive hamstring tightness, as the position described above could produce some discomfort with prolonged subject positioning.
- This investigation is intended to develop methodology and obtain pilot data regarding the existence of coupled proprioception in mature healthy adults. Therefore, subjects below the age of 21 are excluded, as a developing musculoskeletal and central nervous system could impact the outcome of this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 6614298Barrack RL, Skinner HB, Brunet ME, Haddad RJ Jr. Functional performance of the knee after intraarticular anesthesia. Am J Sports Med. 1983 Jul-Aug;11(4):258-61. doi: 10.1177/036354658301100414.
- Background: PubMed 6471834Barrack RL, Skinner HB, Brunet ME, Cook SD. Joint kinesthesia in the highly trained knee. J Sports Med Phys Fitness. 1984 Mar;24(1):18-20. No abstract available.
- Background: PubMed 6465302Barrack RL, Skinner HB, Cook SD. Proprioception of the knee joint. Paradoxical effect of training. Am J Phys Med. 1984 Aug;63(4):175-81.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proprioception, run by National Institutes of Health Clinical Center (CC) 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 2 Jul 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00100919, which also lists 3 linked publications.
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 2 Jul 2017.