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Phantom motor execu...
Phantom motor execution as a treatment for phantom limb pain: Protocol of an international, double-blind, randomised controlled clinical trial
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- Lendaro, Eva, 1989 (author)
- Chalmers tekniska högskola,Chalmers University of Technology,Biomechatronics and Neurorehabilitation Laboratory, Department of Electrical Engineering, Chalmers University of Technology, Goteborg, Sweden
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- Hermansson, Liselotte, 1954- (author)
- Örebro universitet,Institutionen för hälsovetenskaper,Region Örebro län,Department of Prosthetics and Orthotics,TUMA,Örebro University,Örebro läns landsting
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- Burger, H. (author)
- Univerza V Ljubljani,University of Ljubljana,University Rehabilitation Institute, Ljubljana, Slovenia; Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
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- Van Der Sluis, Corry K. (author)
- Rijksuniversiteit Groningen,University of Groningen,Department of Rehabilitation Medicine, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
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- McGuire, Brian E. (author)
- National University of Ireland,School of Psychology & Centre for Pain Research, National University of Ireland, Galway, Ireland
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- Pilch, Monika (author)
- National University of Ireland,School of Psychology & Centre for Pain Research, National University of Ireland, Galway, Ireland
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- Bunketorp-Käll, Lina (author)
- Sahlgrenska universitetssjukhuset,Sahlgrenska University Hospital,Centre for Advanced Reconstruction of Extremities, Sahlgrenska University Hospital, Gothenburg, Sweden
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- Kulbacka-Ortiz, K. (author)
- Sahlgrenska universitetssjukhuset,Sahlgrenska University Hospital,Centre for Advanced Reconstruction of Extremities, Sahlgrenska University Hospital, Gothenburg, Sweden
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- Rignér, Ingrid (author)
- Sahlgrenska universitetssjukhuset,Sahlgrenska University Hospital,Gåskolan/Ortopedteknik, Sahlgrenska Universitetssjukhuset, Göteborg, Sweden
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- Stockselius, A. (author)
- Rehabcenter Sfären, Bräcke Diakoni, Stockholm, Sweden
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Gudmundson, Lena (author)
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- Widehammar, Cathrine, 1969- (author)
- Örebro universitet,Institutionen för hälsovetenskaper,Örebro University
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- Hill, Wendy (author)
- University of New Brunswick,Institute of Biomedical Engineering, University of New Brunswick, Fredericton, New Brunswick, Canada
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- Geers, Sybille (author)
- Fysische Geneeskunde en Revalidatie, University Hospital Gent, Gent, Belgium
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- Ortiz Catalan, Max Jair, 1982 (author)
- Chalmers tekniska högskola,Chalmers University of Technology,Integrum AB,Biomechatronics and Neurorehabilitation Laboratory, Department of Electrical Engineering, Chalmers University of Technology, Göteborg, Sweden; Integrum AB, Mölndal, Sweden
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(creator_code:org_t)
- 2018-07-16
- 2018
- English.
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In: BMJ Open. - : BMJ. - 2044-6055 .- 2044-6055. ; 8:7
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Abstract
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- Introduction Phantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such control have been hypothesised to reverse maladaptive brain changes correlated to PLP. Preliminary investigations have shown that decoding motor volition using myoelectric pattern recognition, while providing real-time feedback via virtual and augmented reality (VR-AR), facilitates phantom motor execution (PME) and reduces PLP. Here we present the study protocol for an international (seven countries), multicentre (nine clinics), double-blind, randomised controlled clinical trial to assess the effectiveness of PME in alleviating PLP. Methods and analysis Sixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned to PME or phantom motor imagery (PMI) interventions. Subjects allocated to either treatment receive 15 interventions and are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are actually performed (PME) or just imagined (PMI). Complete evaluations are conducted at baseline and at intervention completion, as well as 1, 3 and 6 months later using an intention-to-treat (ITT) approach. Changes in PLP measured using the Pain Rating Index between the first and last session are the primary measure of efficacy. Secondary outcomes include: Frequency, duration, quality of pain, intrusion of pain in activities of daily living and sleep, disability associated to pain, pain self-efficacy, frequency of depressed mood, presence of catastrophising thinking, health-related quality of life and clinically significant change as patient's own impression. Follow-up interviews are conducted up to 6 months after the treatment. Ethics and dissemination The study is performed in agreement with the Declaration of Helsinki and under approval by the governing ethical committees of each participating clinic. The results will be published according to the Consolidated Standards of Reporting Trials guidelines in a peer-reviewed journal.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Sjukgymnastik (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Physiotherapy (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Annan medicin och hälsovetenskap -- Övrig annan medicin och hälsovetenskap (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Other Medical and Health Sciences -- Other Medical and Health Sciences not elsewhere specified (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Allmänmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- General Practice (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Arbetsterapi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Occupational Therapy (hsv//eng)
- TEKNIK OCH TEKNOLOGIER -- Medicinteknik -- Annan medicinteknik (hsv//swe)
- ENGINEERING AND TECHNOLOGY -- Medical Engineering -- Other Medical Engineering (hsv//eng)
Keyword
- clinical trials
- neurological pain
- rehabilitation medicine
Publication and Content Type
- art (subject category)
- ref (subject category)
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Lendaro, Eva, 19 ...
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Hermansson, Lise ...
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Burger, H.
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Van Der Sluis, C ...
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McGuire, Brian E ...
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Pilch, Monika
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Bunketorp-Käll, ...
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Kulbacka-Ortiz, ...
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Rignér, Ingrid
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Stockselius, A.
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Gudmundson, Lena
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Widehammar, Cath ...
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Hill, Wendy
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Geers, Sybille
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Ortiz Catalan, M ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Health Sciences
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and Physiotherapy
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Other Medical an ...
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and Other Medical an ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and General Practice
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Health Sciences
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and Occupational The ...
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ENGINEERING AND ...
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BMJ Open
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Chalmers University of Technology
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Örebro University