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

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
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.

Conditions
-----------------
Phantom Limb Pain

Intervention / Treatment
-----------------
* Other: Physical/Occupational therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average intensity of phantom limb pain | 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 |  | At baseline, 4 and 6 weeks following baseline and at 6 months follow-up | 
| Change in duration of phantom limb pain |  | 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 | Measurement instrument: PDI, PSFS | At baseline, 4 and 6 weeks following baseline and at 6 months follow-up | 
| Change in pain specific self-efficacy | 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 | Measurement instrument: EQ-5D-5L | At baseline, 4 and 6 weeks following baseline and at 6 months follow-up | 
| Change in global perceived effect | 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 | Measurement instrument: Neuropathic Pain Symptom Inventory (NPSI) | At baseline, 4 and 6 weeks following baseline and at 6 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telerehabilitation, mirror therapy, phantom limb pain