The Impact of a Virtual Reality Environment on Phantom Li... | NCT03934528

Studies
The Impact of a Virtual Reality Environment on Phantom Limb Pain

NCT03934528

Sponsor

University of Manchester

Status

Withdrawn

Last Update Posted

Apr 30, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Phantom Limb Syndrome With Pain

Interventions

Virtual environment activity

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to proceed during lockdown; post-lockdown vendor no longer supports the hardware on which the study was developed

Expanded Access Info

Start Date

Jun 2019Estimated

Primary Completion Date

Sep 2019Estimated

Completion Date

Nov 2019Estimated

First Submitted Date

Apr 23, 2019

First Submission Date that Met QC Criteria

Apr 30, 2019

First Posted Date

May 2, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2025

Last Update Posted Date

Apr 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Phantom limb pain occurs in the majority of people who lose a limb. It significantly affects quality of life and is hard to manage. Recent evidence suggests that mirror therapy and similar techniques that create a visual representation of the missing limb under the control of the patient may reduce phantom limb pain.

The investigators previously explored the use of a virtual reality environment for this purpose with people with upper limb loss but found that using it within the clinical setting limited its potential efficacy. Phantom limb pain is highly variable and assessing the effects of the activity during a hospital appointment when the phantom pain may not be present, or may not be problematic, made it difficult to judge the effects adequately.

This study involves training the patient in the clinic to use a portable, self-contained virtual reality system which they will then use at home, unsupervised, for 2 months. The aim is to discover whether phantom limb pain intensity decreases by performing an activity in a virtual reality environment in which a visual representation of the missing limb is controlled by the patient. Participants will be directed to use the system every day, and whenever their phantom limb pain is present and problematic.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pilot Study	Experimental		Device: Virtual environment activity

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual environment activity	Device	Patients undertake an activity using simulated arm movement within a virtual reality environment every day for two months	Pilot Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in intensity of phantom limb pain using a numerical rating scale: 0=no pain present to 10=worst imaginable pain.		2 months

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline of number of phantom limb pain episodes per month.		2 months
Change from baseline of average duration of phantom limb pain episodes.		2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 18 years of age.
Unilateral upper limb amputee (transradial and transhumeral).
Amputation occurred at least 6 months ago.
Stump has fully healed and has no ulcerations present.

Exclusion Criteria:

Amputation of digit(s) only.
The presence of a wound, ulcer or broken skin on the residual limb.
The presence of a psychiatric disorder.
Have pre-existing binocular vision abnormalities.
A history of seizures or epilepsy.
A pacemaker or other implanted medical device that could be affected by magnets or components that emit radio waves.
Lacking the capacity to understand the instructions on how to use the virtual reality equipment.
Lacking the capacity to consent.
Unable to comply with the requirements of the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Manchester University NHS Foundation Trust		Manchester		M13 9WL	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D010591	Phantom Limb

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

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