Evaluation of the Imperial College Prosthetic Suspension Systems in providing increased limb control and comfort

ISRCTN	ISRCTN16061457
DOI	https://doi.org/10.1186/ISRCTN16061457
Sponsor	National Institute for Health Research
Funder	National Institute for Health and Care Research

Submission date: 06/01/2026
Registration date: 08/01/2026
Last edited: 07/01/2026

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration.

Contact information

Prof Anthony Bull
Principal investigator, Scientific, Public

Room 514a Sir Michael Uren Hub, Imperial College London, White City Campus
London
W12 0BZ
United Kingdom

Phone	+44 020 7594 5186
Email	a.bull@imperial.ac.uk

Dr Angus Clark
Scientific, Public

Room 514 Sir Michael Uren Hub, Imperial College London, White City Campus
London
W12 0BZ
United Kingdom

Phone	+44 07961610316
Email	ac6117@ic.ac.uk

Study information

Primary study design	Interventional
Allocation	Non-randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Crossover
Purpose	Device feasibility, Health services research, Treatment
Participant information sheet	48779_PIS.pdf
Scientific title	In adult lower-limb prosthesis users in Cambodia, are the Imperial College Prosthetic Suspension Systems, compared with existing prostheses and basic cushion liners, effective in providing increased limb control and comfort?
Study objectives
Ethics approval(s)	Approved 15/11/2025, National Ethic Committee for Health Research (NECHR) (#80, Samdach Penn Nouth Blvd, Sangkat Boeungkok 2, Khan Tuol Kork, Phnom Penh, 120408, Cambodia; +855 012 528 789; nouthsarida@gmail.com), ref: 714
Health condition(s) or problem(s) studied	Unilateral transtibial or transfemoral amputation
Intervention	Two novel prosthetic suspension systems (pin lock and lanyard) for integration with ICRC polypropylene prostheses have been developed by colleagues at Imperial College London. These will be provided to participants (50% pin lock, 50% lanyard. Assigned randomly) and compared with both their original prosthesis (PE-lite liner), as well as a control prosthesis that uses a cushion liner. Each device will be provided for a minimum of 8 weeks, with measurements taken at 0, 2, 4, and 8 weeks. Half of the participants will start with the control prosthesis, and the other with the novel prosthesis. After 8 weeks, they will swap to their other prosthesis. The research protocol will be conducted in several phases, and consists of data collection from the participant in the following ways: 1. Questionnaires (Prosthetic Limb Users Survey of Mobility - PLUS-M, Modified Satisfaction with Prosthesis – SAT-PRO) 2. Quantitative measurements of mobility and pistoning captured by prosthetists.
Intervention type	Device
Phase	Phase II/III
Drug / device / biological / vaccine name(s)	Imperial College Pin-Lock Suspension System, Imperial College Lanyard Suspension System, Cushion Liners, PE-lite liners
Primary outcome measure(s)	Effect on amputee daily life measured using Questionnaires (PLUS-M and SATPRO) and measurements (Pistoning and 2MWT) at 0, 2, 4, and 8 weeks
Key secondary outcome measure(s)
Completion date	31/05/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	32
Total final enrolment	32
Key inclusion criteria	1. 18 ≤ age ≤ 60 years old 2. Weight ≤ 100 kg 3. Unilateral transfemoral or transtibial amputee 4. Experienced prosthesis user (> 18 months) 5. Has been an amputee for > 24 months 6. Healthy (no other disability or health issues other than lower limb amputation)
Key exclusion criteria	1. Age < 18 years old, or 60 years old < age 2. 100 kg < Weight 3. Bilateral amputation 4. Any other recognised disability other than lower limb amputation 5. Pregnant 6. Unable to provide consent for the procedures detailed in the protocol 7. Has undergone lower-limb surgery in the last 6 months
Date of first enrolment	18/06/2025
Date of final enrolment	31/12/2025

Locations

Countries of recruitment

Cambodia

Study participating centre

Department of Prosthetics and Orthotics in the Faculty of Prosthetic and Orthotic Engineering at the National Institute of Social Affairs (DPO)

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Cambodia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Study outputs

Output type	Details	Date added	Peer reviewed?	Patient-facing?
Other files		07/01/2026	No	No
Other files		07/01/2026	No	No
Other files	version 1.2	07/01/2026	No	No
Other files		07/01/2026	No	No
Participant information sheet		07/01/2026	No	Yes

Additional files

48779_PIS.pdf: Participant information sheet
48779_Modified SATPRO Questionnaire.pdf: Other files
48779_Participant Amputation Questionaire.pdf: Other files
48779_PLUS-M12-Item Questionnaire_v1.2.pdf: Other files
48779_ConsentForm.pdf: Other files

Editorial Notes

07/01/2026: Study’s existence confirmed by the National Ethic Committee for Health Research (NECHR), Cambodia.