Neuromuscular Stimulation for Rehabilitation After General and Vascular Surgery - a Pilot Randomised Clinical Study

Imperial College London1 site in 1 country103 target enrollmentJuly 7, 2021

ConditionsSurgery Vascular Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Surgery
Sponsor: Imperial College London
Enrollment: 103
Locations: 1
Primary Endpoint: Safety and Acceptability of NMES as an adjunct for rehabilitation
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 7, 2021

End Date

March 1, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Imperial College London

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Safety and Acceptability of NMES as an adjunct for rehabilitation

Time Frame: 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 Outcomes

Time to return to baseline mobility and independence(At discharge from hospital (completion of study) - up to 28 days)
Rockwood Frailty Index(At discharge from hospital (completion of study) - up to 28 days)
Standing for >1 minute(At discharge from hospital (completion of study) - up to 28 days)
Walking >50m(At discharge from hospital (completion of study) - up to 28 days)
Generic Quality of life - EQ VAS(At discharge from hospital (completion of study) - up to 28 days)
6 Minute Walk(At discharge from hospital (completion of study) - up to 28 days)
Compliance with device usage(At discharge from hospital (completion of study) - up to 28 days)
Incremental cost-utility ratio, comparing NMES with standard care(At discharge from hospital (completion of study) - up to 28 days)
Length of stay(At discharge from hospital (completion of study) - up to 28 days)
Time taken to achieve - Sitting for >5 minutes(At discharge from hospital (completion of study) - up to 28 days)
Hospital Resource use(At discharge from hospital (completion of study) - up to 28 days)
Generic Quality of life - SF-36(At discharge from hospital (completion of study) - up to 28 days)
Barthel Index(At discharge from hospital (completion of study) - up to 28 days)
Satisfaction with device(At discharge from hospital (completion of study) - up to 28 days)
Timed Up and Go(At discharge from hospital (completion of study) - up to 28 days)
Q Frailty(At discharge from hospital (completion of study) - up to 28 days)
Generic Quality of life - EQ-5D(At discharge from hospital (completion of study) - up to 28 days)
Functional Independence Measure(At discharge from hospital (completion of study) - up to 28 days)