Kotomi Sakai1,2, Yuichi Yasufuku3, Tomohiko Kamo4, Erika Ota5, Ryo Momosaki6. 1. Setagaya Memorial Hospital, Department of Rehabilitation Medicine, Tokyo, Japan. 2. St. Luke's International University, Graduate School of Public Health, Tokyo, Japan. 3. Kyoto Tachibana University, Department of Physical Therapy, 34 Yamada-cho, Oyake, Yamashina-ku, Kyoto, Japan, 607-8175. 4. Japan University of Health Sciences, School of Health Sciences, 2-555, Hirasuka, Satte-City, Saitama, Japan, 340-0145. 5. St. Luke's International University, Global Health Nursing, Graduate School of Nursing Science, 10-1 Akashi-cho, Chuo-Ku, Tokyo, MS, Japan, 104-0044. 6. Teikyo University School of Medicine University Hospital, Mizonokuchi, Department of Rehabilitation Medicine, 5-1-1 Futako, Takatsu-ku, Kawasaki, Kanagawa, Japan, 213-8507.
Abstract
BACKGROUND: Repetitive peripheral magnetic stimulation (rPMS) is a non-invasive treatment method that can penetrate to deeper structures with painless stimulation to improve motor function in people with physical impairment due to brain or nerve disorders. rPMS for people after stroke has proved to be a feasible approach to improving activities of daily living and functional ability. However, the effectiveness and safety of this intervention for people after stroke currently remain uncertain. This is an update of the review published in 2017. OBJECTIVES: To assess the effects of rPMS in improving activities of daily living and functional ability in people after stroke. SEARCH METHODS: On 7 January 2019, we searched the Cochrane Stroke Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE; Embase; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); PsycINFO; the Allied and Complementary Medicine Database (AMED); Occupational Therapy Systematic Evaluation of Evidence (OTseeker); the Physiotherapy Evidence Database (PEDro); ICHUSHI Web; and six ongoing trial registries. We screened reference lists, and we contacted experts in the field. We placed no restrictions on the language or date of publication when searching electronic databases. SELECTION CRITERIA: We included randomised controlled trials (RCTs) conducted to assess the therapeutic effect of rPMS for people after stroke. Comparisons eligible for inclusion were (1) active rPMS only compared with 'sham' rPMS (a very weak form of stimulation or a sound only); (2) active rPMS only compared with no intervention; (3) active rPMS plus rehabilitation compared with sham rPMS plus rehabilitation; and (4) active rPMS plus rehabilitation compared with rehabilitation only. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion. The same review authors assessed methods and risk of bias, undertook data extraction, and used the GRADE approach to assess the quality of evidence. We contacted trial authors to request unpublished information if necessary. We resolved all disagreements through discussion. MAIN RESULTS: We included four trials (three RCTs and one cross-over trial) involving 139 participants. Blinding of participants and physicians was well reported within all trials. We judged the overall risk of bias across trials as low. Only two trials (with 63 and 18 participants, respectively) provided sufficient information to be included in the meta-analysis. We found no clear effect of rPMS on activities of daily living at the end of treatment (mean difference (MD) -3.00, 95% confidence interval (CI) -16.35 to 10.35; P = 0.66; 1 trial; 63 participants; low-quality evidence) and at the end of follow-up (MD -2.00, 95% CI -14.86 to 10.86; P = 0.76; 1 trial; 63 participants; low-quality evidence) when comparing rPMS plus rehabilitation versus sham plus rehabilitation. We found no statistical difference in improvement of upper limb function at the end of treatment (MD 2.00, 95% CI -4.91 to 8.91; P = 0.57; 1 trial; 63 participants; low-quality evidence) and at the end of follow-up (MD 4.00, 95% CI -2.92 to 10.92; P = 0.26; 1 trial; 63 participants; low-quality evidence) when comparing rPMS plus rehabilitation versus sham plus rehabilitation. We observed a significant decrease in spasticity of the elbow at the end of follow-up (MD -0.48, 95% CI -0.93 to -0.03; P = 0.03; 1 trial; 63 participants; low-quality evidence) when comparing rPMS plus rehabilitation versus sham plus rehabilitation. In terms of muscle strength, rPMS treatment was not associated with improved muscle strength of the ankle dorsiflexors at the end of treatment (MD 3.00, 95% CI -2.44 to 8.44; P = 0.28; 1 trial; 18 participants; low-quality evidence) when compared with sham rPMS. No studies provided information on lower limb function or adverse events, including death. Based on the GRADE approach, we judged the quality of evidence related to the primary outcome as low, owing to the small sample size of the studies. AUTHORS' CONCLUSIONS: Available trials provided insufficient evidence to permit any conclusions about routine use of rPMS for people after stroke. Additional trials with large sample sizes are needed to provide robust evidence for rPMS after stroke.
BACKGROUND: Repetitive peripheral magnetic stimulation (rPMS) is a non-invasive treatment method that can penetrate to deeper structures with painless stimulation to improve motor function in people with physical impairment due to brain or nerve disorders. rPMS for people after stroke has proved to be a feasible approach to improving activities of daily living and functional ability. However, the effectiveness and safety of this intervention for people after stroke currently remain uncertain. This is an update of the review published in 2017. OBJECTIVES: To assess the effects of rPMS in improving activities of daily living and functional ability in people after stroke. SEARCH METHODS: On 7 January 2019, we searched the Cochrane Stroke Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE; Embase; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); PsycINFO; the Allied and Complementary Medicine Database (AMED); Occupational Therapy Systematic Evaluation of Evidence (OTseeker); the Physiotherapy Evidence Database (PEDro); ICHUSHI Web; and six ongoing trial registries. We screened reference lists, and we contacted experts in the field. We placed no restrictions on the language or date of publication when searching electronic databases. SELECTION CRITERIA: We included randomised controlled trials (RCTs) conducted to assess the therapeutic effect of rPMS for people after stroke. Comparisons eligible for inclusion were (1) active rPMS only compared with 'sham' rPMS (a very weak form of stimulation or a sound only); (2) active rPMS only compared with no intervention; (3) active rPMS plus rehabilitation compared with sham rPMS plus rehabilitation; and (4) active rPMS plus rehabilitation compared with rehabilitation only. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion. The same review authors assessed methods and risk of bias, undertook data extraction, and used the GRADE approach to assess the quality of evidence. We contacted trial authors to request unpublished information if necessary. We resolved all disagreements through discussion. MAIN RESULTS: We included four trials (three RCTs and one cross-over trial) involving 139 participants. Blinding of participants and physicians was well reported within all trials. We judged the overall risk of bias across trials as low. Only two trials (with 63 and 18 participants, respectively) provided sufficient information to be included in the meta-analysis. We found no clear effect of rPMS on activities of daily living at the end of treatment (mean difference (MD) -3.00, 95% confidence interval (CI) -16.35 to 10.35; P = 0.66; 1 trial; 63 participants; low-quality evidence) and at the end of follow-up (MD -2.00, 95% CI -14.86 to 10.86; P = 0.76; 1 trial; 63 participants; low-quality evidence) when comparing rPMS plus rehabilitation versus sham plus rehabilitation. We found no statistical difference in improvement of upper limb function at the end of treatment (MD 2.00, 95% CI -4.91 to 8.91; P = 0.57; 1 trial; 63 participants; low-quality evidence) and at the end of follow-up (MD 4.00, 95% CI -2.92 to 10.92; P = 0.26; 1 trial; 63 participants; low-quality evidence) when comparing rPMS plus rehabilitation versus sham plus rehabilitation. We observed a significant decrease in spasticity of the elbow at the end of follow-up (MD -0.48, 95% CI -0.93 to -0.03; P = 0.03; 1 trial; 63 participants; low-quality evidence) when comparing rPMS plus rehabilitation versus sham plus rehabilitation. In terms of muscle strength, rPMS treatment was not associated with improved muscle strength of the ankle dorsiflexors at the end of treatment (MD 3.00, 95% CI -2.44 to 8.44; P = 0.28; 1 trial; 18 participants; low-quality evidence) when compared with sham rPMS. No studies provided information on lower limb function or adverse events, including death. Based on the GRADE approach, we judged the quality of evidence related to the primary outcome as low, owing to the small sample size of the studies. AUTHORS' CONCLUSIONS: Available trials provided insufficient evidence to permit any conclusions about routine use of rPMS for people after stroke. Additional trials with large sample sizes are needed to provide robust evidence for rPMS after stroke.