NMES for Rehab After Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04784962
• Other study ID #: P84082
• Secondary ID: 28130920CX6284
• Status: Completed
• Phase: N/A
• Start date: July 7, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: August 2022
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Medically stable after index surgery

• Willing and able to participate in study protocol

• All ethnic groups, male or female above the age of 18 years

• Baseline Rockwood Frailty Score of 3 or greater

Exclusion Criteria

• Inability or unwillingness to participate in trial

• Implanted electrical device such as Pacemaker or defibrillator.

• Pregnant

• Acute deep vein thrombosis

• Previous use of NMES device

Related Conditions & MeSH terms

• Surgery
• Vascular Diseases

Intervention

Device:
• Revitive Medic Neuromuscular Stimulation Device
Usage of the Revitive NMES device - 1-6 sessions daily (30 minutes per session).
• Revitive Medic Neuromuscular Stimulation Device (Sham)
Usage of the Sham Revitive NMES device - 1-6 sessions daily (30 minutes per session)

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

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