SurgeryNCT04784962
NMES for Rehab After Surgery
A study testing Revitive Medic Neuromuscular Stimulation Device in people with Surgery and Vascular Diseases, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Vascular Diseases
- What is being tested?
- Revitive Medic Neuromuscular Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jul 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular Stimulation for Rehabilitation After General and Vascular Surgery - a Pilot Randomised Clinical Study
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.
Read the 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.
- Conditions
- Surgery, Vascular Diseases
- Being tested
- Revitive Medic Neuromuscular Stimulation Device, Revitive Medic Neuromuscular Stimulation Device (Sham)
- Keywords
- rehabilitation
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revitive Medic Neuromuscular Stimulation DeviceDevice
Usage of the Revitive NMES device - 1-6 sessions daily (30 minutes per session).
Revitive Medic Neuromuscular Stimulation Device (Sham)Device
Usage of the Sham Revitive NMES device - 1-6 sessions daily (30 minutes per session)
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Sham comparator | Sham device Receives: Device: Revitive Medic Neuromuscular Stimulation Device (Sham) |
| Intervention Arm | Experimental | Standard rehabilitation care including physiotherapy + Adjunctive Neuromuscular Stimulation Device Usage Receives: Device: Revitive Medic Neuromuscular Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At discharge from hospital (completion of study) - up to 28 days
Secondary outcomes (18)
Time to return to baseline mobility and independence
Time in days to return to pre-operative mobility and independence
Measured: At discharge from hospital (completion of study) - up to 28 days
Generic Quality of life - SF-36
Generic quality of life values at entry and exit of study utilising the Short Form 36 health profile
Measured: At discharge from hospital (completion of study) - up to 28 days
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
Measured: At discharge from hospital (completion of study) - up to 28 days
Generic Quality of life - EQ VAS
Generic quality of life values at entry and exit of study utilising the EuroQol Visual Analogue Scale
Measured: At discharge from hospital (completion of study) - up to 28 days
Functional Independence Measure
Scoring tool of ability to function independently at entry and exit of study
Measured: At discharge from hospital (completion of study) - up to 28 days
Barthel Index
Scoring tool of independence at entry and exit of study
Measured: At discharge from hospital (completion of study) - up to 28 days
Rockwood Frailty Index
Frailty index scoring tool at entry and exit of study
Measured: At discharge from hospital (completion of study) - up to 28 days
Satisfaction with device
User satisfaction with NMES device assessed by qualitative feedback and assessment
Measured: At discharge from hospital (completion of study) - up to 28 days
Length of stay
Hospital Length of stay
Measured: At discharge from hospital (completion of study) - up to 28 days
6 Minute Walk
Distance walked in 6 minutes at entry and exit of study
Measured: At discharge from hospital (completion of study) - up to 28 days
Timed Up and Go
Time taken to stand and walk from sitting in a chair at entry and exit of study
Measured: At discharge from hospital (completion of study) - up to 28 days
Compliance with device usage
User compliance with NMES device as assessed with usage diary and qualitative feedback
Measured: At discharge from hospital (completion of study) - up to 28 days
Q Frailty
Frailty assessment scale at entry and exit of study
Measured: At discharge from hospital (completion of study) - up to 28 days
Time taken to achieve - Sitting for >5 minutes
Mobility Milestone
Measured: At discharge from hospital (completion of study) - up to 28 days
Standing for >1 minute
Mobility Milestone
Measured: At discharge from hospital (completion of study) - up to 28 days
Walking >50m
Mobility Milestone
Measured: At discharge from hospital (completion of study) - up to 28 days
Hospital Resource use
Contacts with rehabilitation professionals during the using of NMES
Measured: At discharge from hospital (completion of study) - up to 28 days
Incremental cost-utility ratio, comparing NMES with standard care
Cost-effectiveness analysis
Measured: At discharge from hospital (completion of study) - up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start7 Jul 2021
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alun H Davies, DM DSC FRCS, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784962
- Sponsor's protocol ID
- P84082
- Other IDs
- 281309, 20CX6284
- Status last verified
- Aug 2022
- First submitted
- 23 Feb 2021
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be available following publication to requesting researchers.
Publications
Nimura M, Lane T, Rawashdeh M, Onida S, Javed A, Sritharan G, Reese G, Hrouda D, Davies AH. Study protocol for neuromuscular stimulation for rehabilitation after general and vascular surgery: a pilot randomised clinical study. BMJ Open. 2023 Feb 16;13(2):e061800. doi: 10.1136/bmjopen-2022-061800.
PubMed 36797015
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Stimulation for Rehabilitation After General and Vascular Surgery - a Pilot Randomised Clinical Study
- ClinicalTrials.gov ID
- NCT04784962
- Acronym / sponsor ID
- P84082
- Conditions
- Surgery, Vascular Diseases
- Keywords
- rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Sham comparator | Device: Revitive Medic Neuromuscular Stimulation Device (Sham)Sham device |
| Intervention Arm | Experimental | Device: Revitive Medic Neuromuscular Stimulation DeviceStandard rehabilitation care including physiotherapy + Adjunctive Neuromuscular Stimulation Device Usage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revitive Medic Neuromuscular Stimulation DeviceUsage of the Revitive NMES device - 1-6 sessions daily (30 minutes per session). | Device | Intervention Arm |
| Revitive Medic Neuromuscular Stimulation Device (Sham)Usage of the Sham Revitive NMES device - 1-6 sessions daily (30 minutes per session) | Device | Control Arm |
Primary outcome
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
18 secondary outcomes
Time to return to baseline mobility and independence
Time frame: At discharge from hospital (completion of study) - up to 28 days
Generic Quality of life - SF-36
Time frame: At discharge from hospital (completion of study) - up to 28 days
Generic Quality of life - EQ-5D
Time frame: At discharge from hospital (completion of study) - up to 28 days
Generic Quality of life - EQ VAS
Time frame: At discharge from hospital (completion of study) - up to 28 days
Functional Independence Measure
Time frame: At discharge from hospital (completion of study) - up to 28 days
Barthel Index
Time frame: At discharge from hospital (completion of study) - up to 28 days
Rockwood Frailty Index
Time frame: At discharge from hospital (completion of study) - up to 28 days
Satisfaction with device
Time frame: At discharge from hospital (completion of study) - up to 28 days
Length of stay
Time frame: At discharge from hospital (completion of study) - up to 28 days
6 Minute Walk
Time frame: At discharge from hospital (completion of study) - up to 28 days
Timed Up and Go
Time frame: At discharge from hospital (completion of study) - up to 28 days
Compliance with device usage
Time frame: At discharge from hospital (completion of study) - up to 28 days
Q Frailty
Time frame: At discharge from hospital (completion of study) - up to 28 days
Time taken to achieve - Sitting for >5 minutes
Time frame: At discharge from hospital (completion of study) - up to 28 days
Standing for >1 minute
Time frame: At discharge from hospital (completion of study) - up to 28 days
Walking >50m
Time frame: At discharge from hospital (completion of study) - up to 28 days
Hospital Resource use
Time frame: At discharge from hospital (completion of study) - up to 28 days
Incremental cost-utility ratio, comparing NMES with standard care
Time frame: At discharge from hospital (completion of study) - up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Derived from this study: PubMed 36797015Nimura M, Lane T, Rawashdeh M, Onida S, Javed A, Sritharan G, Reese G, Hrouda D, Davies AH. Study protocol for neuromuscular stimulation for rehabilitation after general and vascular surgery: a pilot randomised clinical study. BMJ Open. 2023 Feb 16;13(2):e061800. doi: 10.1136/bmjopen-2022-061800.
- Individual participant dataSharing planned: Yes. Anonymised data will be available following publication to requesting researchers.
Related trials for Surgery
Not yet recruiting
The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases
mERAS Intervention, The ASA (American Society of Anesthesiologists) Score
RecruitingObservational study
Label-free Femtosecond Laser Imaging Combined With the Fast Lung Artificial Intelligence Model for Rapid Intraoperative Diagnosis of Lung Surgical Specimens: A Multicentre, Prospective, Parallel-workflow, Non-inferiority Study.
Lung Cancer
RecruitingPhase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Ganglioneuroblastoma, Nodular, Neuroblastoma
Not yet recruiting
The Effect of Compound Chamomile and Lidocaine Hydronchloride Gel as an Endotracheal Tube Lubricant on Postoperative Pharyngeal and Laryngeal Complications in Thoracic Surgery Patients
Postoperative Sore Throat
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alun H Davies, DM DSC FRCS principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revitive Medic Neuromuscular Stimulation Device in people with Surgery and Vascular Diseases, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Acceptability of NMES as an adjunct for rehabilitation (time frame: At discharge from hospital (completion of study) - up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04784962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.