Multiple SclerosisHHDNCT01749943
Validation of Hand Held Dynamometer for Assessment of Lower Limb Muscle Strength in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Brown, Theodore R., M.D., MPH at 1 site in United States.
Trial summary
Evaluate a method of testing the strength of five key lower limb muscle groups using a hand-held strength gauge (dynamometer). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stable patients with clinically definite Multiple Sclerosis, aged 18 over, no Multiple Sclerosis exacerbation or change in disease modifying therapy for 30 days prior to screening. Subjects will fall into 1 of 3 EDSS catagories: 0-3.5; 4.0-5.5; 6.0-7.5.
Who may be able to join
- Stable patients with clinically definite Multiple Sclerosis
- No Multiple Sclerosis exacerbation 30 days prior to screening
- No change in disease modifying therapy for 30 day prior to screening
Who cannot join
- Inflammatory myopathy
- Endocarditis, pericarditis o rother unstable heart disease
- Cardiac surgery or myocardial infarction in the last 3 months
- Decompensated congestive heart failure
- Severe aortic stenosis
- Severe pulmonary hypertension
Show all 13Show fewer
- Pulmonary embolus or infarction in the last 6 months
- Uncontrolled hypertension by history or by screening or baseline diastolic blood pressure >170 or systolic blood pressure >105
- Concomitant neurodegenerative neurological disease such as Amyotrophic Lateral Sclerosis (ALS) Parkinsons or hemiplegic stroke
- females who are pregnant
- Cognitive deficits that would interfere with the subjects's ability to give informed consent or preform study testing
- Painful orthopedic condition affecting the lower limbs
- Any other serious and/or unstable medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
MS Center at Evergreen Hospital
Kirkland, Washington, 98034
About this study
Official title: Validation of a Hand-Held Dynamometer for Assessment of Lower Limb Muscle Strength in Multiple Sclerosis: Protocol for Strength Testing and Reliability Characteristics
Evaluate a method of testing the strength of five key lower limb muscle groups using a hand-held strength gauge (dynamometer).
Read the detailed description
Purpose of this study is to assess the intra-rater and inter-rater reliability of a hand-held dynamometer (HHD) in the assessment of lower limb strength in patients with Multiple Sclerosis.
Also to establish a standardized strength testing procedure for key lower limb muscle groups using a HHD fo research and clinical purposes in Multiple Sclerosis.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EDSS Score 0-3.5 | 21 Subjects Total : 7 with normal to mildly limited walking | |
| EDSS Score 4.0-5.5 | 21 Subjects total: 7 subjects with moderately limited walking ability. | |
| EDSS Score 6.0-7.5 | 21 Subjects total: 7 subjects with severely limited walking ability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of HHD
To assess the intra-rater and inter-rater reliability of a hand-held dynamometer(HHD) in the assessment of lower limb strength in patients with Multiple Sclerosis.
To establish a standardized strength testing procedure for key lower limb muscle groups using a HHD for research and clinical purposes in Multiple Sclerosis.
Measured: Outcome measures will be assessed once we have captured all data points for all 21 subjects.
Secondary outcomes (1)
Validation of a Hand-held dynamometer for assessment of lower limb muscle strength.
to establish a standardized strength testing procedure for key lower limb muscle groups using a Hand-held dynamometer for research and clinical purposes in Multiple Sclerosis.
Measured: outcome measures will be assessed once we have captured all data points for all 21 subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown, Theodore R., M.D., MPH
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Theodore R Brown, MD, Principal investigator, MS Center at Evergreen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749943
- Sponsor's protocol ID
- US-AVX-11-10213
- Acronym
- HHD
- Status last verified
- Aug 2013
- First submitted
- 26 Nov 2012
- Last updated
- 22 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Hand-Held Dynamometer for Assessment of Lower Limb Muscle Strength in Multiple Sclerosis: Protocol for Strength Testing and Reliability Characteristics
- ClinicalTrials.gov ID
- NCT01749943
- Acronym / sponsor ID
- HHD / US-AVX-11-10213
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Brown, Theodore R., M.D., MPH
- Collaborators
- Biogen
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 Dec 2012 (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.
Evaluate a method of testing the strength of five key lower limb muscle groups using a hand-held strength gauge (dynamometer).
Detailed description
Purpose of this study is to assess the intra-rater and inter-rater reliability of a hand-held dynamometer (HHD) in the assessment of lower limb strength in patients with Multiple Sclerosis.
Also to establish a standardized strength testing procedure for key lower limb muscle groups using a HHD fo research and clinical purposes in Multiple Sclerosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EDSS Score 0-3.5 | – | –21 Subjects Total : 7 with normal to mildly limited walking |
| EDSS Score 4.0-5.5 | – | –21 Subjects total: 7 subjects with moderately limited walking ability. |
| EDSS Score 6.0-7.5 | – | –21 Subjects total: 7 subjects with severely limited walking ability |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable patients with clinically definite Multiple Sclerosis, aged 18 over, no Multiple Sclerosis exacerbation or change in disease modifying therapy for 30 days prior to screening. Subjects will fall into 1 of 3 EDSS catagories: 0-3.5; 4.0-5.5; 6.0-7.5.
Key inclusion criteria (3 listed)
- Stable patients with clinically definite Multiple Sclerosis
- No Multiple Sclerosis exacerbation 30 days prior to screening
- No change in disease modifying therapy for 30 day prior to screening
Key exclusion criteria (13 listed)
- Inflammatory myopathy
- Endocarditis, pericarditis o rother unstable heart disease
- Cardiac surgery or myocardial infarction in the last 3 months
- Decompensated congestive heart failure
- Severe aortic stenosis
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
Assessment of HHD
Time frame: Outcome measures will be assessed once we have captured all data points for all 21 subjects.
To assess the intra-rater and inter-rater reliability of a hand-held dynamometer(HHD) in the assessment of lower limb strength in patients with Multiple Sclerosis. To establish a standardized strength testing procedure for key lower limb muscle groups using a HHD for research and clinical purposes in Multiple Sclerosis.
1 secondary outcome
Validation of a Hand-held dynamometer for assessment of lower limb muscle strength.
Time frame: outcome measures will be assessed once we have captured all data points for all 21 subjects
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 22 Aug 2013.
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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.
Theodore R Brown, MD principal investigator
MS Center at Evergreen Hospital
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 Multiple Sclerosis, run by Brown, Theodore R., M.D., MPH 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 3 inclusion and 13 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 22 Aug 2013. 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.
What does the primary outcome measure?
Assessment of HHD (time frame: Outcome measures will be assessed once we have captured all data points for all 21 subjects.). 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 22 Aug 2013.