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: protocol of a multicentre randomised controlled trial.
abstract: BACKGROUND
  Non-pharmacological interventions such as mirror therapy are gaining increased recognition in the treatment of phantom limb pain; however, the evidence in people with phantom limb pain is still weak. In addition, compliance to self-delivered exercises is generally low. The aim of this randomised controlled study is to investigate the effectiveness of mirror therapy supported by telerehabilitation on the intensity, duration and frequency of phantom limb pain and limitations in daily activities compared to traditional mirror therapy and care as usual in people following lower limb amputation.
  
  
  METHODS
  A three-arm multi-centre randomised controlled trial will be performed. Participants will be randomly assigned to care as usual, traditional mirror therapy or mirror therapy supported by telerehabilitation. During the first 4 weeks, at least 10 individual sessions will take place in every group. After the first 4 weeks, participants will be encouraged to perform self-delivered exercises over a period of 6 weeks. Outcomes will be assessed at 4 and 10 weeks after baseline and at 6 months follow-up. The primary outcome measure is the average intensity of phantom limb pain during the last week. Secondary outcome measures include the different dimensions of phantom limb pain, pain-related limitations in daily activities, global perceived effect, pain-specific self-efficacy, and quality of life.
  
  
  CONCLUSIONS
  Several questions concerning the study design that emerged during the preparation of this trial will be discussed. This will include how these questions were addressed and arguments for the choices that were made.
authors.affiliation: Department of Rehabilitation, Research School CAPHRI, Maastricht University; Research Centre Autonomy and Participation of People with a Chronic Illness, Faculty of Health, Zuyd University of Applied Sciences.
authors.forename: Andreas Stefan
authors.initials: AS
authors.lastname: Rothgangel
authors.affiliation: Research Centre Autonomy and Participation of People with a Chronic Illness, Faculty of Health, Zuyd University of Applied Sciences; Research Centre Technology in Care, Faculty of Health, Zuyd University of Applied Sciences, Heerlen; Department Health Research Services, Research School CAPHRI, Maastricht University.
authors.forename: Susy
authors.initials: S
authors.lastname: Braun
authors.affiliation: Department of Geriatrics, Cologne University.
authors.forename: Ralf Joachim
authors.initials: RJ
authors.lastname: Schulz
authors.affiliation: Centre of Neurological Rehabilitation, St. Marien Hospital Cologne, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Kraemer
authors.affiliation: Research Centre Technology in Care, Faculty of Health, Zuyd University of Applied Sciences, Heerlen; Department Health Research Services, Research School CAPHRI, Maastricht University.
authors.forename: Luc
authors.initials: L
authors.lastname: de Witte
authors.affiliation: Research Centre Autonomy and Participation of People with a Chronic Illness, Faculty of Health, Zuyd University of Applied Sciences; Department of Family Medicine, Research School CAPHRI, Maastricht University, Maastricht.
authors.forename: Anna
authors.initials: A
authors.lastname: Beurskens
authors.affiliation: Department of Rehabilitation, Research School CAPHRI, Maastricht University; Adelante Centre of Expertise in Rehabilitation, Hoensbroek, The Netherlands.
authors.forename: Rob Johannes
authors.initials: RJ
authors.lastname: Smeets
mesh_terms: D000671:Amputation, Surgical; D005081:Exercise Therapy; D006801:Humans; D035002:Lower Extremity; D010147:Pain Measurement; D010349:Patient Compliance; D010591:Phantom Limb / Q000534:rehabilitation*; D011788:Quality of Life; D012107:Research Design; D012984:Software; D000069350:Telerehabilitation; D016896:Treatment Outcome