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NCT04112901
Effects of Microprocessor-controlled Knee Joints on Community Outcomes
trial testing Microprocessor-controlled knee joints in People With Trans-femoral Amputation in 330 participants. Status unknown.
1 May 2020
Quick facts
| Lead sponsor | University of Derby |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 330 |
| Start date | 15 January 2020 |
| Primary completion | 1 May 2020 |
| Estimated completion | 30 May 2020 |
Drugs / interventions tested
- Microprocessor-controlled knee joints
- Non-microprocessor-controlled knee joints
Conditions studied
- People With Trans-femoral Amputation — all drugs for People With Trans-femoral Amputation →
Sponsor
University of Derby
Who can join
Adults 18 to 95, any sex, with People With Trans-femoral Amputation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
About 21% to 35% of people with limb loss are those who lost their limb at trans-femoral level (i.e. above the knee). The increasing number of diabetes-related limb loss (amputation) and the rising proportion of older adult amputees indicates more amputees with limited mobility in the future. Among other factors, prosthesis success highly depends on the function of the knee joints during daily activities. Presently, there are two categories of prosthetic knee joints; microprocessor-controlled knees (MPKs) and non-microprocessor-controlled knees (n-MPKs). Whilst the n-MPKs are unable to change the knee stiffness, the MPKs alter the joint stiffness and speed of movement according to the users' walking speed. Although past studies indicate that MPKs could result in reduced risk of falls, improved balance and activity in limited mobility amputees, there is a lack of strong evidence on the effect of MPKs on community outcomes. The aim of this study is to compare activity, mobility, social functioning, depression, anxiety, and health-related quality of life in limited mobility trans-femoral or through-knee (i.e. knee disarticulation) amputees who are users of MPKs prosthesis with users of a prosthesis with n-MPKs.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04112901 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Derby
- Last refreshed: 2 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04112901.
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