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

NCT ID: NCT02076490

Last Updated: 2014-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-12-31

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.

Conditions

Phantom Limb Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Software Supported Mirror Therapy

First experimental condition Physical/Occupational Therapy

Group Type: EXPERIMENTAL

Physical/Occupational therapy

Intervention Type: OTHER

At least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase.

Traditional mirror therapy

Second experimental condition Physical/Occupational Therapy

Group Type: EXPERIMENTAL

Physical/Occupational therapy

Intervention Type: OTHER

At least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase.

Sensomotor exercises without mirror

Control condition Physical/Occupational Therapy

Group Type: ACTIVE_COMPARATOR

Physical/Occupational therapy

Intervention Type: OTHER

At least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase.

Interventions

Physical/Occupational therapy

At least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University

OTHER

Sponsor Role: collaborator

Zuyd University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rob J Smeets, Prof., Dr.

Role: STUDY_DIRECTOR

Research School CAPHRI, Maastricht University, Maastricht, The Netherlands

References

Rothgangel AS, Braun S, Schulz RJ, Kraemer M, de Witte L, Beurskens A, Smeets RJ. 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. J Physiother. 2015 Jan;61(1):42; discussion 42. doi: 10.1016/j.jphys.2014.08.006. Epub 2014 Oct 16.

Reference Type: DERIVED

PMID: 25439709 (View on PubMed)

Other Identifiers

005-GW02-035

Identifier Type: -

Identifier Source: org_study_id