Telerehabilitation Using Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation.

February 27, 2014 updated by: Zuyd University of Applied Sciences

The PACT Trial - PAtient Centered Telerehabilitation: Effectiveness of Software-supported and Traditional Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation: Design of a Randomized Controlled Trial.

The overall aim of this randomized controlled study is to investigate the effectiveness of mirror therapy supported by telerehabilitation on the intensity, duration and frequency of phantom limb pain and daily activities compared to traditional mirror therapy and sensomotor exercises without a mirror in patients following lower limb amputation.

Study Overview

Status

Unknown

Conditions

Detailed Description

Up to 75% of patients after amputation of an arm or leg suffer from chronic phantom limb pain that still is perceived in the missing limb, leading to limitations in daily activities and quality of life. The treatment of phantom limb pain is still challenging. Despite many different pharmacological interventions, the outcomes on the longer-term are in many cases not satisfying. Alternative, non-pharmacological interventions, such as mirror therapy, are gaining increased recognition in the treatment of phantom limb pain. In this context, telerehabilitation plays an important role to support long-term self-management and autonomy of these patients.

In the developmental phase of the project, a user-centred design is applied. Patients as well as physical and occupational therapists are interviewed concerning their preferences and needs with respect to the design and content of the telerehabilitation. Additionally, two focus groups with each five participants will be conducted. Subsequently, a prototype of the telerehabilitation will be developed based on user preferences, available evidence, expert opinion and already existing systems. This prototype will be tested on its usability and technical performance in phase three using the thinking-aloud-method and data logging. Accordingly, a multicenter, randomized controlled trial will be conducted to evaluate the cost-effectiveness of the telerehabilitation.

Study Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Lower limb amputation
  2. At least since one week constant or intermittent phantom limb pain (PLP) with an average intensity of at least score 3 on the 11-point NRS and a minimum frequency of one episode of PLP per week.
  3. Sufficient cognitive, communicative and motor functions to be able to use the telerehabilitation service, to concentrate for at least 15 minutes on the mirror image and to follow instructions and questionnaires; this is based on clinical judgment of recruiting physicians or therapists.

    Exclusion Criteria:

  4. Duration of inpatient rehabilitation not long enough to ensure the 4-week clinical intervention phase.
  5. Bilateral amputation, severe co-morbidity (e.g. stroke) or pain affecting the intact limb; this prevents engagement in the prescribed exercise programs of the study.
  6. Severe psychiatric disorders that preclude patients from participating in the trial.
  7. Intensive course of mirror therapy in the past (> 6 treatments during the last three months).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Software Supported Mirror Therapy
First experimental condition Physical/Occupational Therapy
At least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase.
Experimental: Traditional mirror therapy
Second experimental condition Physical/Occupational Therapy
At least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase.
Active Comparator: Sensomotor exercises without mirror
Control condition Physical/Occupational Therapy
At least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in average intensity of phantom limb pain
Time Frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Measurement instrument: 11-point NRS
At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in frequency of phantom limb pain
Time Frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in duration of phantom limb pain
Time Frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
At baseline, 4 and 6 weeks following baseline and at 6 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain related limitations in daily activities
Time Frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Measurement instrument: PDI, PSFS
At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in pain specific self-efficacy
Time Frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Measurement instrument: Pain specific self-efficacy scale
At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in quality of life
Time Frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Measurement instrument: EQ-5D-5L
At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in global perceived effect
Time Frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Measurement instrument: GPE scale
At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in dimensions of phantom limb pain
Time Frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Measurement instrument: Neuropathic Pain Symptom Inventory (NPSI)
At baseline, 4 and 6 weeks following baseline and at 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Rob J Smeets, Prof., Dr., Research School CAPHRI, Maastricht University, Maastricht, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Estimate)

March 3, 2014

Last Update Submitted That Met QC Criteria

February 27, 2014

Last Verified

February 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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