- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02076490
Telerehabilitation Using Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Lower limb amputation
- 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.
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:
- Duration of inpatient rehabilitation not long enough to ensure the 4-week clinical intervention phase.
- 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.
- Severe psychiatric disorders that preclude patients from participating in the trial.
- Intensive course of mirror therapy in the past (> 6 treatments during the last three months).
Study Plan
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
Collaborators
Investigators
- Study Director: Rob J Smeets, Prof., Dr., Research School CAPHRI, Maastricht University, Maastricht, The Netherlands
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 005-GW02-035
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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