Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
103 participants
INTERVENTIONAL
2021-07-07
2022-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control Arm
Sham device
Revitive Medic Neuromuscular Stimulation Device (Sham)
Usage of the Sham Revitive NMES device - 1-6 sessions daily (30 minutes per session)
Intervention Arm
Standard rehabilitation care including physiotherapy + Adjunctive Neuromuscular Stimulation Device Usage
Revitive Medic Neuromuscular Stimulation Device
Usage of the Revitive NMES device - 1-6 sessions daily (30 minutes per session).
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* Implanted electrical device such as Pacemaker or defibrillator.
* Pregnant
* Acute deep vein thrombosis
* Previous use of NMES device
18 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Alun H Davies, DM DSC FRCS
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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281309
Identifier Type: OTHER
Identifier Source: secondary_id
20CX6284
Identifier Type: OTHER
Identifier Source: secondary_id
P84082
Identifier Type: -
Identifier Source: org_study_id
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