Amputation of Hip and Thigh, Level UnspecifiedNCT02382991
Assessment of Disability Compensation With the C-LEG COMPACT 2 Knee (Ref. 3C60 et 3C60=ST)
A study testing 3C60-NMPK and NMPK-3C60 in people with Amputation of Hip and Thigh, Level Unspecified, run by Otto Bock France SNC at 15 sites in 3 countries.
Trial summary
Moderately active amputees may have lost their limb due to diabetes, vascular conditions, trauma, tumour or congenital causes. These amputees currently cannot benefit from having a computerised knee because of the performance criteria associated with being given one. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amputation of Hip and Thigh, Level Unspecified
- What is being tested?
- 3C60-NMPK and NMPK-3C60
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 15 sitesin 3 countries
- Study dates
- Mar 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Person with leg amputation above knee or knee disarticulation with stabilized residual limb
- Person who are currently fitted with a prosthesis using a non-microprocessor controlled prosthetic knee
- Person with a high risk of falling, which is defined as a TGUG test score of more than 19 seconds
- Person who moves around within buildings other than one's residence, such as moving around other people's homes, other private buildings, community and private or public buildings and enclosed areas, moving throughout all parts of buildings and enclosed areas, between floors, inside, outside and around buildings, both public and private
- Person who moves around outside the home and other buildings, such as walking and moving around close to or far from one's home and other buildings, without the use of transportation, public or private, such as walking for short or long distances around a town or village, walking or moving down streets in the neighbourhood, town, village or city; moving between cities and further distances, without using transportation
- Person with a daily walking distance greater than 300 m
Who cannot join
- Persons using underarm crutches or walkers
- Persons under 18 years of age
- Persons who weigh more than 125 kg
- Pregnant women
- Persons in an emergency situation
- Persons who cannot personally provide their consent
- Persons who are not available to follow the entire study protocol
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
France13 sites
CRMPR "Les Herbiers"
Bois-Guillaume, 76230
Hôpital d'instruction des Armées Percy
Clamart, 92141
Centre Hospitalier de Cornouaille Concarneau
Concarneau, 29900
Centre de réadaptation de Coubert
Coubert, 77170
CHU de Grenoble Hôpital Sud
Échirolles, 38434
Clinique Chantecler
Marseille, 13012
Institut Régional de Médecine Physique et de Réadaptation
Nancy, 54042
Institut National des Invalides
Paris, 75007
Hôpital Léopold Belan
Paris, 75010
Pôle Saint-Hélier
Rennes, 35043
Hôpital privé de l'Est Lyonnais
Saint-Priest, 69794
Centre l'Adapt Thionis
Thionville, 57100
Institut Robert Merle d'Aubigné
Valenton, 94460
About this study
Official title: Randomized, Cross-over Study Comparing the Efficacy of the 3C60 Knee Against Non-microprocessor Controlled Knees on the Risk of Falling and Locomotor Skills of Moderately Active Persons With Leg Amputation Above Knee or Knee Disarticulation
Moderately active amputees may have lost their limb due to diabetes, vascular conditions, trauma, tumour or congenital causes. These amputees currently cannot benefit from having a computerised knee because of the performance criteria associated with being given one. However, these amputees have a very high risk of falling because they use a non microprocessor controlled knee joint (NMPK) and because their physical ability, associated disability and persistent contralateral leg weakness do not allow them to compensate for a balance deficit. These amputees restrict how much they move around and their participation because of their instability and elevated risk of falling.
The objective of the study is to evaluate the effect of the 3C60 knee, a microprocessor-controlled knee joint for external leg prosthesis, on the reduction in the risk of falling after three months in moderately active persons with leg amputation above knee or knee disarticulation.
Read the detailed description
The patient will be evaluated after one month of using his/her usual non micropressor controlled knee joint (NMPK). After fitting of the 3C60, the patient will undergo at least five rehabilitation sessions, adapted to his/her individual needs, so that he/she knows how to use the device and is ready to go along with the planned testing.
After the trial with the 3C60 knee, the patient will again be fitted with his/her non microprocessor controlled knee joint (NMPK) and will be required to undergo one rehabilitation session to regain his/her walking abilities.
- Being tested
- 3C60-NMPK, NMPK-3C60
- Keywords
- Moderately active amputees, C-leg Compact, Knee prosthesis, Kenevo, Microprocessor controlled knee, Amputation, 3C60, Timed Get Up and Go (TGUG), Locomotors Capacities Index (LCI), QUEST, Short Form survey (SF-36)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3C60-NMPKDevice
Also called Mechanical knee joint
3 months with 3C60 - 10 days wash out - 1 month with NMPK
NMPK-3C60Device
Also called C-LEG COMPACT 2, KENEVO
1 month with NMPK - 3 months with 3C60
| Study group | Role | What they receive |
|---|---|---|
| NMPK-3C60 | Other | D0 + 30 days: evaluation with the non-microprocessor knee. D1 + 90 days: evaluation with the 3C60 knee. Receives: Device: 3C60-NMPK |
| 3C60-NMPK | Other | D0 + 90 days: evaluation with the 3C60 knee. A period of 10 days of "wash out". D1 + 30 days: evaluation with the non-microprocessor knee. Receives: Device: NMPK-3C60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Get Up and Go (TGUG)
This test consists of recording the amount of time needed for a person to stand up from a chair, walk 3 metres, make a half-turn and sit down again. The TGUG test score reflects a person's balance and as a consequence, the risk of falling.
Measured: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
Secondary outcomes (5)
Locomotor Capabilities Index (LCI-5)
The Locomotor Capabilities Index (LCI-5) is a 14 item self-assessment questionnaire filled in by the patient that explores walking and ambulation. The LCI-5 is derived from the Prosthesis Profile of the Amputee Questionnaire (PPA). LCI-5 is sensitive to the use of walking aids or to the need of a third party. Ceiling effect is not expected with moderately active amputees. The global LCI-5 score is the addition of the 14 scores, noted between 0 and 4. The global score varies between 0 and 56, the highest being for persons with high locomotors capabilities. LCI-5 has two sub-scores: the basic score corresponds to 7 questions related to basic activities and the advanced score corresponds to 7 questions related to more advanced activities. The basic and advanced scores both range from 0-28. Higher scores correspond with a better outcome.
Measured: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
Use of Walking Aids
The type of walking aids used with each device will be recorded.
Measured: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
QUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)
It is a self-evaluation questionnaire of the user's satisfaction, translated in French (ESAT) and in German (QUEST 2.0-G Section 17.5). The QUEST 2.0 questionnaire contains 8 items that evaluate the device's technology and 4 items that evaluate services surrounding the device. It allows patients to express themselves on the criteria that are most important to them. Each item has a score that varies between 0 (not satisfied at all) and 5 (very satisfied). The global score is the average obtained onto the 12 items. Two sub-scores related to the technology and services can also be calculated. They correspond to the average of the 8 first items and to the 4 last items respectively. All scores ranks between 0 and 5, 5 being the highest level of satisfaction.
Measured: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
SF-36v2™ Health Survey
36-Item Short Form Health Survey (SF-36v2TM) explores 8 dimensions of quality of life through 36 questions: PF= Physical Functioning (10 items), RP= Role Physical (4 items), BP = Bodily Pain (2 items), SF= Social Functioning (2 items), MH= Mental Health (5 items), RE= Role emotional (3 items), VT= Vitality (4 items), GH= General Health (5 items). All of the eight health domain scales contributes with different levels to score two component summary measures: PCS= Physical Component Summary and MCS= Mental Component Summary. All scores are calculated online through scoring software. Domain scales and component summary are ranging from 0 to 100. A high score is considered to be a better outcome, as indicating little or no problem.
Measured: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
Number of Falls
Measured: Measurement will be performed at 1 month with both devices
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Amputation of Hip and Thigh, Level UnspecifiedStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otto Bock France SNC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Chiesa, Physician, Principal investigator, Institut Robert Merle d'Aubigné - 2 rue du Parc 94460 Valenton - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382991
- Sponsor's protocol ID
- 20PT002-FR-01-0614
- Other IDs
- 2014-A00754-43
- Status last verified
- Sep 2019
- First submitted
- 25 Feb 2015
- Last updated
- 23 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schoppen T, Boonstra A, Groothoff JW, de Vries J, Goeken LN, Eisma WH. The Timed "up and go" test: reliability and validity in persons with unilateral lower limb amputation. Arch Phys Med Rehabil. 1999 Jul;80(7):825-8. doi: 10.1016/s0003-9993(99)90234-4.
PubMed 10414769Dite W, Connor HJ, Curtis HC. Clinical identification of multiple fall risk early after unilateral transtibial amputation. Arch Phys Med Rehabil. 2007 Jan;88(1):109-14. doi: 10.1016/j.apmr.2006.10.015.
PubMed 17207685Franchignoni F, Orlandini D, Ferriero G, Moscato TA. Reliability, validity, and responsiveness of the locomotor capabilities index in adults with lower-limb amputation undergoing prosthetic training. Arch Phys Med Rehabil. 2004 May;85(5):743-8. doi: 10.1016/j.apmr.2003.06.010.
PubMed 15129398Gauthier-Gagnon C, Grise MC, Potvin D. Enabling factors related to prosthetic use by people with transtibial and transfemoral amputation. Arch Phys Med Rehabil. 1999 Jun;80(6):706-13. doi: 10.1016/s0003-9993(99)90177-6.
PubMed 10378500Burnfield JM, Eberly VJ, Gronely JK, Perry J, Yule WJ, Mulroy SJ. Impact of stance phase microprocessor-controlled knee prosthesis on ramp negotiation and community walking function in K2 level transfemoral amputees. Prosthet Orthot Int. 2012 Mar;36(1):95-104. doi: 10.1177/0309364611431611. Epub 2012 Jan 5.
PubMed 22223685Gauthier-Gagnon, C, grisé, MCL, Lepage Y. The Locomotor Capabilities Index : Content validity. J rehabil OutcomesMeas 2(4) : 40-46, 1998.
Gauthier-Gagnon C, Grise MC. Prosthetic profile of the amputee questionnaire: validity and reliability. Arch Phys Med Rehabil. 1994 Dec;75(12):1309-14.
PubMed 7993169Grise MC, Gauthier-Gagnon C, Martineau GG. Prosthetic profile of people with lower extremity amputation: conception and design of a follow-up questionnaire. Arch Phys Med Rehabil. 1993 Aug;74(8):862-70. doi: 10.1016/0003-9993(93)90014-2.
PubMed 8347072Demers L, Weiss-Lambrou R, Ska B. Development of the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST). Assist Technol. 1996;8(1):3-13. doi: 10.1080/10400435.1996.10132268.
PubMed 10159726Leplege A, Mesbah M, Marquis P. [Preliminary analysis of the psychometric properties of the French version of an international questionnaire measuring the quality of life: the MOS SF-36 (version 1.1)]. Rev Epidemiol Sante Publique. 1995;43(4):371-9. French.
PubMed 7667543Leplège, A. (2001). Introduction, enjeux, définitions. In J. Coste et A. Leplège (Eds.), Mesure de la santé perceptuelle et de la qualité de vie : méthodes et applications (pp 15-36). Paris : Editions Estem
Ware JE, Snow KK, Kosinski M, Gandek B (1993). Health survey : manual and interpretation guide. Boston, Massachussets : The Health Institute, New England Medical Center, 1993
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914Loiret I, Paysant J, Martinet N, Andre JM. [Evaluation of amputees]. Ann Readapt Med Phys. 2005 Jul;48(6):307-16. doi: 10.1016/j.annrmp.2005.03.009. Epub 2005 Apr 15. French.
PubMed 15932782
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Cross-over Study Comparing the Efficacy of the 3C60 Knee Against Non-microprocessor Controlled Knees on the Risk of Falling and Locomotor Skills of Moderately Active Persons With Leg Amputation Above Knee or Knee Disarticulation
- ClinicalTrials.gov ID
- NCT02382991
- Acronym / sponsor ID
- 20PT002-FR-01-0614
- Keywords
- Moderately active amputees, C-leg Compact, Knee prosthesis, Kenevo, Microprocessor controlled knee, Amputation, 3C60, Timed Get Up and Go (TGUG)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Otto Bock France SNCIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Posted 23 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Moderately active amputees may have lost their limb due to diabetes, vascular conditions, trauma, tumour or congenital causes. These amputees currently cannot benefit from having a computerised knee because of the performance criteria associated with being given one. However, these amputees have a very high risk of falling because they use a non microprocessor controlled knee joint (NMPK) and because their physical ability, associated disability and persistent contralateral leg weakness do not allow them to compensate for a balance deficit. These amputees restrict how much they move around and their participation because of their instability and elevated risk of falling.
The objective of the study is to evaluate the effect of the 3C60 knee, a microprocessor-controlled knee joint for external leg prosthesis, on the reduction in the risk of falling after three months in moderately active persons with leg amputation above knee or knee disarticulation.
Detailed description
The patient will be evaluated after one month of using his/her usual non micropressor controlled knee joint (NMPK). After fitting of the 3C60, the patient will undergo at least five rehabilitation sessions, adapted to his/her individual needs, so that he/she knows how to use the device and is ready to go along with the planned testing.
After the trial with the 3C60 knee, the patient will again be fitted with his/her non microprocessor controlled knee joint (NMPK) and will be required to undergo one rehabilitation session to regain his/her walking abilities.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMPK-3C60 | Other | Device: 3C60-NMPKD0 + 30 days: evaluation with the non-microprocessor knee. D1 + 90 days: evaluation with the 3C60 knee. |
| 3C60-NMPK | Other | Device: NMPK-3C60D0 + 90 days: evaluation with the 3C60 knee. A period of 10 days of "wash out". D1 + 30 days: evaluation with the non-microprocessor knee. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Person with leg amputation above knee or knee disarticulation with stabilized residual limb
- Person who are currently fitted with a prosthesis using a non-microprocessor controlled prosthetic knee
- Person with a high risk of falling, which is defined as a TGUG test score of more than 19 seconds
- Person who moves around within buildings other than one's residence, such as moving around other people's homes, other private buildings, community and private or public buildings and enclosed areas, moving throughout all parts of buildings and enclosed areas, between floors, inside, outside and around buildings, both public and private
- Person who moves around outside the home and other buildings, such as walking and moving around close to or far from one's home and other buildings, without the use of transportation, public or private, such as walking for short or long distances around a town or village, walking or moving down streets in the neighbourhood, town, village or city; moving between cities and further distances, without using transportation
Key exclusion criteria (7 listed)
- Persons using underarm crutches or walkers
- Persons under 18 years of age
- Persons who weigh more than 125 kg
- Pregnant women
- Persons in an emergency situation
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 |
|---|---|---|
| 3C60-NMPKAlso: Mechanical knee joint3 months with 3C60 - 10 days wash out - 1 month with NMPK | Device | NMPK-3C60 |
| NMPK-3C60Also: C-LEG COMPACT 2, KENEVO1 month with NMPK - 3 months with 3C60 | Device | 3C60-NMPK |
Primary outcome
Timed Get Up and Go (TGUG)
Time frame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
This test consists of recording the amount of time needed for a person to stand up from a chair, walk 3 metres, make a half-turn and sit down again. The TGUG test score reflects a person's balance and as a consequence, the risk of falling.
5 secondary outcomes
Locomotor Capabilities Index (LCI-5)
Time frame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
Use of Walking Aids
Time frame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
QUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)
Time frame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
SF-36v2™ Health Survey
Time frame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
Number of Falls
Time frame: Measurement will be performed at 1 month with both devices
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10414769Schoppen T, Boonstra A, Groothoff JW, de Vries J, Goeken LN, Eisma WH. The Timed "up and go" test: reliability and validity in persons with unilateral lower limb amputation. Arch Phys Med Rehabil. 1999 Jul;80(7):825-8. doi: 10.1016/s0003-9993(99)90234-4.
- Background: PubMed 17207685Dite W, Connor HJ, Curtis HC. Clinical identification of multiple fall risk early after unilateral transtibial amputation. Arch Phys Med Rehabil. 2007 Jan;88(1):109-14. doi: 10.1016/j.apmr.2006.10.015.
- Background: PubMed 15129398Franchignoni F, Orlandini D, Ferriero G, Moscato TA. Reliability, validity, and responsiveness of the locomotor capabilities index in adults with lower-limb amputation undergoing prosthetic training. Arch Phys Med Rehabil. 2004 May;85(5):743-8. doi: 10.1016/j.apmr.2003.06.010.
- Background: PubMed 10378500Gauthier-Gagnon C, Grise MC, Potvin D. Enabling factors related to prosthetic use by people with transtibial and transfemoral amputation. Arch Phys Med Rehabil. 1999 Jun;80(6):706-13. doi: 10.1016/s0003-9993(99)90177-6.
- Background: PubMed 22223685Burnfield JM, Eberly VJ, Gronely JK, Perry J, Yule WJ, Mulroy SJ. Impact of stance phase microprocessor-controlled knee prosthesis on ramp negotiation and community walking function in K2 level transfemoral amputees. Prosthet Orthot Int. 2012 Mar;36(1):95-104. doi: 10.1177/0309364611431611. Epub 2012 Jan 5.
- BackgroundGauthier-Gagnon, C, grisé, MCL, Lepage Y. The Locomotor Capabilities Index : Content validity. J rehabil OutcomesMeas 2(4) : 40-46, 1998.
- Background: PubMed 7993169Gauthier-Gagnon C, Grise MC. Prosthetic profile of the amputee questionnaire: validity and reliability. Arch Phys Med Rehabil. 1994 Dec;75(12):1309-14.
- Background: PubMed 8347072Grise MC, Gauthier-Gagnon C, Martineau GG. Prosthetic profile of people with lower extremity amputation: conception and design of a follow-up questionnaire. Arch Phys Med Rehabil. 1993 Aug;74(8):862-70. doi: 10.1016/0003-9993(93)90014-2.
- Background: PubMed 10159726Demers L, Weiss-Lambrou R, Ska B. Development of the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST). Assist Technol. 1996;8(1):3-13. doi: 10.1080/10400435.1996.10132268.
- Background: PubMed 7667543Leplege A, Mesbah M, Marquis P. [Preliminary analysis of the psychometric properties of the French version of an international questionnaire measuring the quality of life: the MOS SF-36 (version 1.1)]. Rev Epidemiol Sante Publique. 1995;43(4):371-9. French.
- BackgroundLeplège, A. (2001). Introduction, enjeux, définitions. In J. Coste et A. Leplège (Eds.), Mesure de la santé perceptuelle et de la qualité de vie : méthodes et applications (pp 15-36). Paris : Editions Estem
- BackgroundWare JE, Snow KK, Kosinski M, Gandek B (1993). Health survey : manual and interpretation guide. Boston, Massachussets : The Health Institute, New England Medical Center, 1993
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.
Gerard Chiesa, Physician principal investigator
Institut Robert Merle d'Aubigné - 2 rue du Parc 94460 Valenton - France
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3C60-NMPK and NMPK-3C60 in people with Amputation of Hip and Thigh, Level Unspecified, run by Otto Bock France SNC at 15 sites in 3 countries.
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 7 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 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Austria, Germany. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Timed Get Up and Go (TGUG) (time frame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02382991, which also lists 14 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 23 Oct 2019.