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

NCT02076490 | Unknown DMC

• 1 other identifier: 005-GW02-035
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Phantom Limb Pain

Keywords

Telerehabilitation, mirror therapy, phantom limb pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Change in pain related limitations in daily activities

  At baseline, 4 and 6 weeks following baseline and at 6 months follow-up

• Change in pain specific self-efficacy

  At baseline, 4 and 6 weeks following baseline and at 6 months follow-up

• Change in quality of life

  At baseline, 4 and 6 weeks following baseline and at 6 months follow-up

• Change in global perceived effect

  At baseline, 4 and 6 weeks following baseline and at 6 months follow-up

• Change in dimensions of phantom limb pain

  At baseline, 4 and 6 weeks following baseline and at 6 months follow-up

Study Arms (3)

Software Supported Mirror Therapy

EXPERIMENTAL

First experimental condition Physical/Occupational Therapy

Other: Physical/Occupational therapy

Traditional mirror therapy

EXPERIMENTAL

Second experimental condition Physical/Occupational Therapy

Other: Physical/Occupational therapy

Sensomotor exercises without mirror

ACTIVE COMPARATOR

Control condition Physical/Occupational Therapy

Other: Physical/Occupational therapy

Interventions

Physical/Occupational therapy 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; Software Supported Mirror Therapy; Traditional mirror therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zuyd University of Applied Sciences: lead
• Maastricht University: collaborator

Related Publications (1)

• 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.

  PMID: 25439709 DERIVED

MeSH Terms

Conditions

Phantom Limb

Interventions

Restraint, Physical; Occupational Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Rob J Smeets, Prof., Dr.

  Research School CAPHRI, Maastricht University, Maastricht, The Netherlands

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: March 3, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 3, 2014

Record last verified: 2014-02