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Functional Muscle Transfers in Lower Limb Sarcoma: 3D Gait Analysis and Environmental Simulation

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ClinicalTrials.gov Identifier: NCT04911972
Recruitment Status : Completed
First Posted : June 3, 2021
Last Update Posted : July 28, 2021
Sponsor:
Collaborator:
University of Strathclyde
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Brief Summary:
The purpose of this study is to assess patient's function after functional limb restoring surgery, performed after ablative tumour surgery or trauma. However, there are no studies as yet providing objective proof of the recovery of function after this type of surgery. This study will use 3D Gait Analysis, Environmental simulation and Patient Reported Outcome Measures to compare patients with function restoring surgery against patients without function restoring surgery.

Condition or disease Intervention/treatment
Sarcoma Muscle Tumor Muscle Loss Procedure: Functional muscle transfer

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Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Muscle Transfers to Restore Normal Function After Major Lower Limb Sarcoma/ Trauma - Assessment by Gait Analysis and Virtual Reality Environmental Simulation
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : July 1, 2021
Actual Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Functional muscle transfer group
Patients who have undergone functional muscle transfer to restore function after tumour surgery or injury, in which the tumour surgery or injury has resulted in functional loss.
Procedure: Functional muscle transfer
Muscle transfer to restore lower limb function

Non-functional muscle transfer group
Patients who have not undergone functional muscle transfer to restore function after tumour surgery or injury, in which the tumour surgery or injury has resulted in functional loss.



Primary Outcome Measures :
  1. Gait Profile Score (GPS) [ Time Frame: Up to 10 years after surgery. From date of surgery, but after completion of post-operative rehabilitation at 6 months up to 10 years following surgery ]
    Objective score from 3D Gait Analysis. This is a continuous score with no minimum or maximum score, where lower scores indicate better gait.


Secondary Outcome Measures :
  1. Environmental Simulator assessment of ability to complete Tasks of Daily Living [ Time Frame: Up to 10 years after surgery. From date of surgery, but after completion of post-operative rehabilitation at 6 months up to 10 years following surgery ]
    Descriptive outcome measure on ability to complete simulator tasks which replicate activities of daily living.

  2. Toronto Extremity Salvage Score (TESS) [ Time Frame: Up to 10 years after surgery. From date of surgery, but after completion of post-operative rehabilitation at 6 months up to 10 years following surgery ]
    Patient reported outcome measure on function after surgery. This is a continuous score which is converted to a 0 to 100 score. Higher indicates better functional outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Population study groups will be taken from the Scottish Sarcoma Network Glasgow centre's patient cohort
Criteria

Inclusion Criteria:

  • Patients who have undergone major surgery for tumour, resulting in significant muscle loss in the West of Scotland
  • At least 3 months post-surgery

Exclusion Criteria:

  • Patients with ongoing surgical complications
  • < 3 months post-surgery
  • Patients currently undergoing radiotherapy
  • Patients with known motion sickness (related to Virtual Reality component of gait analysis)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04911972


Locations
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United Kingdom
Canniesburn Regional Plastic Surgery and Burns Unit
Glasgow, Scotland, United Kingdom, G4 0SF
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Strathclyde
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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT04911972    
Other Study ID Numbers: GN17OR618
First Posted: June 3, 2021    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be shared on reasonable written request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms