NMES for Rehab After Surgery

Not Applicable

Completed

• Conditions: Surgery; Vascular Diseases

• Registration Number: NCT04784962
• Lead Sponsor: Imperial College London

Brief Summary

A randomised pilot study assessing the acceptability and feasibility of utilising neuromuscular stimulation devices to enhance post-operative rehabilitation and recovery after general, vascular and urological surgery procedures.

Detailed Description

Patients undergoing inpatient rehabilitation after general, vascular or urological surgery will be invited to take part in a randomised study utilising either sham or active neuromuscular stimulation devices to enhance post-operative rehabilitation and physiotherapy.

Study Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-05
• Study Start: 2021-07-07
• Primary Completion: 2022-02-01
• Study Completion: 2022-03-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-01
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety and Acceptability of NMES as an adjunct for rehabilitation	At discharge from hospital (completion of study) - up to 28 days	Qualitiative assessment of participant satisfaction and acceptance of NMES device as an adjunct to standard rehabilitation via semi-structured interview

Secondary Outcome Measures

Name	Time	Method
Time to return to baseline mobility and independence	At discharge from hospital (completion of study) - up to 28 days	Time in days to return to pre-operative mobility and independence
Rockwood Frailty Index	At discharge from hospital (completion of study) - up to 28 days	Frailty index scoring tool at entry and exit of study
Standing for >1 minute	At discharge from hospital (completion of study) - up to 28 days	Mobility Milestone
Walking >50m	At discharge from hospital (completion of study) - up to 28 days	Mobility Milestone
Generic Quality of life - EQ VAS	At discharge from hospital (completion of study) - up to 28 days	Generic quality of life values at entry and exit of study utilising the EuroQol Visual Analogue Scale
6 Minute Walk	At discharge from hospital (completion of study) - up to 28 days	Distance walked in 6 minutes at entry and exit of study
Compliance with device usage	At discharge from hospital (completion of study) - up to 28 days	User compliance with NMES device as assessed with usage diary and qualitative feedback
Incremental cost-utility ratio, comparing NMES with standard care	At discharge from hospital (completion of study) - up to 28 days	Cost-effectiveness analysis
Length of stay	At discharge from hospital (completion of study) - up to 28 days	Hospital Length of stay
Time taken to achieve - Sitting for >5 minutes	At discharge from hospital (completion of study) - up to 28 days	Mobility Milestone
Hospital Resource use	At discharge from hospital (completion of study) - up to 28 days	Contacts with rehabilitation professionals during the using of NMES
Generic Quality of life - SF-36	At discharge from hospital (completion of study) - up to 28 days	Generic quality of life values at entry and exit of study utilising the Short Form 36 health profile
Barthel Index	At discharge from hospital (completion of study) - up to 28 days	Scoring tool of independence at entry and exit of study
Satisfaction with device	At discharge from hospital (completion of study) - up to 28 days	User satisfaction with NMES device assessed by qualitative feedback and assessment
Timed Up and Go	At discharge from hospital (completion of study) - up to 28 days	Time taken to stand and walk from sitting in a chair at entry and exit of study
Q Frailty	At discharge from hospital (completion of study) - up to 28 days	Frailty assessment scale at entry and exit of study
Generic Quality of life - EQ-5D	At discharge from hospital (completion of study) - up to 28 days	Generic quality of life values at entry and exit of study utilising the EuroQol 5 Domain (EQ-5D) Health Metric
Functional Independence Measure	At discharge from hospital (completion of study) - up to 28 days	Scoring tool of ability to function independently at entry and exit of study

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom