The Use of NMES With Pelvic Fracture Rehabilitation

NCT03298425 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2017-10-02

No results posted yet for this study

Summary

The purpose of the study is to investigate if using an electrical stimulation machine to see if it can help strengthen the muscles around the hip during the first three months post pelvic fracture will help with the early stages of rehabilitation. Electrical stimulation is a treatment machine that uses an electrical current to cause a single muscle or a group of muscles to contract. This contraction helps strengthen injured muscles and helps with the healing process. It can also help with pain relief by blocking pain signals from the brain.

After a pelvic fracture they are surgically fixed and will be advised not to put any weight on the operated leg for 10 weeks. During this time hip muscles become very weak as they will not be used as much as normal. Bed exercises can help keep muscle strength but this study would like to try using electrical stimulation machines alongside bed exercises to see if it can improve muscle strength even more. Electrical stimulation machines are already used by rehabilitation. Electrical stimulation is a treatment machine that uses an electrical current to cause a single muscle or a group of muscles to contract. This contraction helps strengthen injured muscles and helps with the healing process. It can also help with pain relief by blocking pain signals from the brain.

After a pelvic fracture they are surgically fixed and will be advised not to put any weight on the operated leg for 10 weeks. During this time hip muscles become very weak as they will not be used as much as normal. Bed exercises can help keep muscle strength but this study would like to try using electrical stimulation machines alongside bed exercises to see if it can improve muscle strength even more. Electrical stimulation machines are already used by patients to increase muscle strength.

Participants will be put into one of two groups, both groups will be given an electrical stimulation machine but one will be on a placebo setting. Participants will need to use the machine twice a day along with their bed exercises and will need to fill in a diary when and how many times the machine has been used for 10 weeks until their 12 week appointment with the orthopaedic consultant. The participants weight bearing status will change and they will be asked to perform a muscle strength test on both the operated and nonoperated leg. They will also have their walking quality assessed. The results will compare both groups for muscle strength and walking changes.

Conditions

  • Fractures, Closed

Interventions

DEVICE

Treatment NMES

Muscle stimulation to reproduce an active muscle contraction. CE marked used for intended purpose.

DEVICE

Placebo NMES

TENS machine to mimic an active muscle contraction. CE marked used for intended purpose.

Sponsors & Collaborators

  • Barts & The London NHS Trust

    lead OTHER

Principal Investigators

  • Jessica A Rich, MRes · Barts Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-07-31
Completion
2017-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03298425 on ClinicalTrials.gov