Tele-Rehabilitation for Individuals with Multiple Sclerosis and Mobility Disorders—A Feasibility and Pilot Study

Objective: To determine the feasibility of conducting an 8-week physical therapist (PT)-guided tele-rehabilitation (TR) program for persons with multiple sclerosis (MS) and mobility deficits. Design, setting, and participants: This feasibility study had a pre–post-intervention, non-randomized design. Nine subjects with a confirmed diagnosis of MS without a clinical exacerbation in the last year were selected from the MS Center of Excellence at UF Health Jacksonville (UFHJ). Inclusion criteria included demonstrated mobility deficits on initial examination, basic computer competency, and a home with high-speed internet connection. Examinations were performed face-to-face, pre–post-intervention in the Neurology Research Clinic at UFHJ. TR was delivered to the patient’s homes in Florida and South Georgia. Intervention: An informed consent was obtained prior to initial examination. Self-reported measures included quality of life (QOL) and fatigue. Mobility measures included timed 10-m walk, five times sit to stand, and Berg balance scale. Following inclusion, home safety was evaluated and computer equipment was installed. TR intervention utilized the Jintronix® web-based platform system with a kinetic camera that demonstrated selected exercises by an avatar, allowing for real-time feedback on the quality of performance as well as tracking of adherence. The individualized exercises were assigned by the evaluating PT based on the initial assessment. Subjects participated in weekly TR visits with the prescribing PT to further monitor and adjust the therapy program. Main outcome measures: Primary outcome measures were patient satisfaction, safety, and compliance. Secondary outcome measures were projected travel cost, self-reported fatigue and QOL, and mobility testing measures. To compare the TR effect on mobility, a comparator persons with MS group was selected retrospectively. Eight persons with MS referred from the MS Center at UFHJ for outpatient (OP) PT from January 2018 through September 2019 were identified by UFHJ electronic database search for ICD 10 code G35. The inclusion criteria for mobility deficits and functional measurements were the same as those in TR group. Results: Eight subjects completed the TR program with no adverse events. They reported satisfaction, demonstrated compliance, and saved $8,487 in projected travel costs. All TR subjects noted improvement in self-reported fatigue, QOL, or mobility measures. Improvement in mobility measures had wide variability but did not differ between TR and OP groups. Conclusions: The 8-week PT-monitored TR program was shown to be feasible, safe, and well received by persons with MS. Larger studies focused on specific dysfunction leading to mobility deficits and longer intervention times will be necessary to determine efficacy.

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Home-based training to improve manual dexterity in patients with multiple sclerosis: A randomized controlled trial

Multiple Sclerosis Journal ◽

10.1177/1352458514565959 ◽

2015 ◽

Vol 21 (12) ◽

pp. 1546-1556 ◽

Cited By ~ 15

Author(s):

Christian P Kamm ◽

Heinrich P Mattle ◽

René M Müri ◽

Mirjam R Heldner ◽

Verena Blatter ◽

...

Keyword(s):

Multiple Sclerosis ◽

Training Program ◽

Outcome Measures ◽

Controlled Trial ◽

Manual Dexterity ◽

Secondary Outcome ◽

Home Based ◽

Almost All ◽

Nine Hole Peg Test

Background: Impaired manual dexterity is frequent and disabling in patients with multiple sclerosis (MS), affecting activities of daily living (ADL) and quality of life. Objective: We aimed to evaluate the effectiveness of a standardized, home-based training program to improve manual dexterity and dexterity-related ADL in MS patients. Methods: This was a randomized, rater-blinded controlled trial. Thirty-nine MS patients acknowledging impaired manual dexterity and having a pathological Coin Rotation Task (CRT), Nine Hole Peg Test (9HPT) or both were randomized 1:1 into two standardized training programs, the dexterity training program and the theraband training program. Patients trained five days per week in both programs over a period of 4 weeks. Primary outcome measures performed at baseline and after 4 weeks were the CRT, 9HPT and a dexterous-related ADL questionnaire. Secondary outcome measures were the Chedoke Arm and Hand Activity Inventory (CAHAI-8) and the JAMAR test. Results: The dexterity training program resulted in significant improvements in almost all outcome measures at study end compared with baseline. The theraband training program resulted in mostly non-significant improvements. Conclusion: The home-based dexterity training program significantly improved manual dexterity and dexterity-related ADL in moderately disabled MS patients. Trial Registration NCT01507636.

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A Short-Term, Multidisciplinary, Intensive Inpatient Neurorehabilitation Program for Multiple Sclerosis Patients with Moderate Disability: A Pilot Study

International Journal of MS Care ◽

10.7224/1537-2073-12.2.66 ◽

2010 ◽

Vol 12 (2) ◽

pp. 66-70 ◽

Cited By ~ 1

Author(s):

José A. Cabrera-Gómez ◽

Yanely Real-González ◽

Roberto Díaz-Márquez ◽

Alexander Echemendia del Valle ◽

Alina González-Quevedo ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Pilot Study ◽

Outcome Measures ◽

Rating Scale ◽

Secondary Outcome ◽

Short Term ◽

Good Tolerability ◽

Multiple Sclerosis Patients

Intensive inpatient neurorehabilitation may be an effective form of intervention for people with multiple sclerosis (MS) to supplement treatment with disease-modifying agents. The primary objective of this study was to evaluate the tolerability and safety of a personalized, one-on-one, short-term, intensive inpatient neurorehabilitation program for MS patients with moderate disability. Thirty MS patients (diagnosed using Polman criteria) with moderate disability as indicated by Expanded Disability Status Scale (EDSS) score of 5.0 to 6.5 were enrolled in a 4-week intensive inpatient neurorehabilitation program. The primary outcome measures were tolerability and safety. Secondary outcome measures were impairment, disability/activity, handicap/participation, fatigue, and quality of life. The results showed good tolerability, with only three patients (10%) developing transitory neuromuscular fatigue; and safety, with adverse events observed in only six patients (20%). Significant improvement was found in impairment and disability/activity as measured by the Scripps Neurological Rating Scale (P = .000) and the EDSS (P = .001), respectively. The Multiple Sclerosis Quality of Life–54 showed improvement in physical (P = .008) and mental health (P = .026), and the Fatigue Impact Scale showed improvement in fatigue (17 patients) (P = .005). This pilot study demonstrated good tolerability and safety of the short-term inpatient intensive neurorehabilitation program. Impairment, disability/activity, quality of life, and fatigue were improved at the completion of the program. Sustained improvement remains to be determined in future clinical trials.

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SWE and SMI ultrasound techniques for monitoring needling treatment of ankylosing spondylitis: study protocol for a single-blinded randomized controlled trial

Trials ◽

10.1186/s13063-021-05344-z ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Mengyu Wang ◽

Wen Fu ◽

Lingcui Meng ◽

Jia Liu ◽

Lihua Wu ◽

...

Keyword(s):

Quality Of Life ◽

Blood Flow ◽

Ankylosing Spondylitis ◽

Outcome Measures ◽

Healthy Subjects ◽

Acupuncture Group ◽

Musculoskeletal Ultrasound ◽

Sham Control ◽

Post Intervention

Abstract Background Ankylosing spondylitis (AS) is a high-incidence disease in young men that interferes with patients’ physical and mental wellbeing and overall quality of life (QoL). It is often accompanied by arthralgia, stiffness, and limited lumbar flexibility. Acupuncture is safe and effective for reducing the symptoms of AS, but the underlying mechanisms by which it does so are not fully understood. Therefore, to objectively assess acupuncture efficacy, which is critical for patients making informed decisions about appropriate treatments, we will use shear-wave elastography (SWE) and superb microvascular imaging (SMI) ultrasound techniques to evaluate elasticity of lumbar paraspinal muscles and blood flow to the sacroiliac joint (SIJ) in AS. Methods We will recruit a total of 60 participants diagnosed with AS and 30 healthy subjects. Participants will be randomly allocated 1:1 to either an acupuncture group or a sham control acupuncture group. Primary-outcome measures will be musculoskeletal ultrasound, Ankylosing Spondylitis Quality of Life Scale (ASQoL), Bath Ankylosing Spondylitis Metrology Index (BASMI), and the Visual Analogue Scale (VAS) for pain. Secondary outcome measures will be the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Function Index (BASFI), and Fatigue Scale-14 (FS-14). We will monitor the effect of acupuncture or sham acupuncture on blood flow and SIJ inflammation using SMI, lumbar-muscle stiffness using SWE and the lumbar paraspinal-muscle cross-sectional area (CSA) using a two-dimensional (2D) grayscale imaging. QoL, physical function, and fatigue will be assessed using an evaluation scale or questionnaire developed for this study, with outcomes measured by the ASQoL, BASMI, BASDAI, BASFI, and FS-14. Healthy subjects will not receive acupuncture but undergo only musculoskeletal ultrasound at baseline. Acupuncture and sham control acupuncture interventions will be conducted for 30 min, 2–3 times/week for 12 weeks. Musculoskeletal ultrasound will be conducted at baseline and post-intervention, while other outcomes will be measured at baseline, 6 weeks, and post-intervention. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Discussion The results of this single-blinded, randomized trial with sham controls could help demonstrate the efficacy of acupuncture and clarify whether musculoskeletal ultrasound could be used to evaluate AS. Trial registration ClinicalTrials.gov ChiCTR2000031476. Registered 3 April 2020.

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Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-042627 ◽

2021 ◽

Vol 11 (3) ◽

pp. e042627

Author(s):

María Reina-Bueno ◽

María del Carmen Vázquez-Bautista ◽

Inmaculada C Palomo-Toucedo ◽

Gabriel Domínguez-Maldonado ◽

José Manuel Castillo-López ◽

...

Keyword(s):

Quality Of Life ◽

Randomised Controlled Trial ◽

Outcome Measures ◽

Controlled Trial ◽

Secondary Outcome ◽

Foot Orthoses ◽

Systemic Lupus ◽

Custom Made ◽

Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

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Systematic review of the psychometric properties of patient-reported outcome measures for rheumatoid arthritis in the foot and ankle

Clinical Rehabilitation ◽

10.1177/0269215519862328 ◽

2019 ◽

Vol 33 (11) ◽

pp. 1788-1799 ◽

Cited By ~ 2

Author(s):

Ana Belen Ortega-Avila ◽

Laura Ramos-Petersen ◽

Pablo Cervera-Garvi ◽

Christopher J Nester ◽

José Miguel Morales-Asencio ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Systematic Review ◽

Psychometric Properties ◽

Outcome Measures ◽

Methodological Quality ◽

Measurement Properties ◽

Foot And Ankle ◽

Inclusion Criteria ◽

Patient Reported

Objective: To identify self-reported outcome measures specific to the foot and ankle in patients with rheumatoid arthritis and to investigate the methodological quality and psychometric properties of these measures. Method: A systematic review focusing on patients with rheumatoid arthritis. Setting: The search was conducted in the PubMed, SCOPUS, CINAHL, PEDro and Google Scholar databases, based on the following inclusion criteria: population (with rheumatoid arthritis) > 18 years; psychometric or clinimetric validation studies of patient-reported outcomes specific to the foot and ankle, in different languages, with no time limit. Two of the present authors independently assessed the quality of the studies located and extracted the relevant data. Terwee’s criteria and the COSMIN checklist were employed to ensure adequate methodological quality. Results: Of the initial 431 studies considered, 14 met the inclusion criteria, representing 7,793 patients (56.8 years). These instruments were grouped into three dimensions (pain, perceived health status and quality of life and disability). The time to complete any of the PROMs varies around 15 minutes. PROMs criterias with the worst scores by COSMIN, 92.85% and 85.71% were criterion validity, measurement error, internal consistency and responsiveness. 28.57% of PROMs were compared with the measurement properties. Conclusion: the Self-Reported Foot and Ankle Score achieved the highest number of positive criteria (according to Terwee and COSMIN), and is currently the most appropriate for patients with Rheumatoid arthritis.

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Outcome Measures in Multiple Sclerosis

10.1093/med/9780199341016.003.0011 ◽

2016 ◽

Author(s):

Robert M. Herndon

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Clinical Trials ◽

Disease Activity ◽

Outcome Measures

This chapter discusses the challenges involved in measuring disease activity and progression in multiple sclerosis and how different aspects of the disease are measured in clinical trials. Metrics have been developed to assess multiple aspects of the disease., These include, in addition to more global instruments, measures of specific functions such as, cognition, mobility, quality of life, fatigue, and so on. These scales are discussed along with their strengths and weaknesses.

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User experience of transtibial prosthetic liners: A systematic review

Prosthetics and Orthotics International ◽

10.1177/0309364616631343 ◽

2016 ◽

Vol 41 (1) ◽

pp. 6-18 ◽

Cited By ~ 8

Author(s):

Amy Richardson ◽

Michael P Dillon

Keyword(s):

Systematic Review ◽

Outcome Measures ◽

User Experience ◽

Sampling Bias ◽

Inclusion Criteria ◽

High Quality Research ◽

Amputation Level ◽

Inferential Analysis ◽

Person Experience

Background:The liner is an integral part of a transtibial prosthesis designed to protect the residual limb, enhance comfort and provide suspension. Literature is difficult to interpret and use given the variety of interventions, outcome measures and method designs. Critical appraisal and synthesis of the evidence is needed to help inform decisions about liner prescription based on the user experience.Objectives:To critically appraise and synthesise research describing the user experience of transtibial prosthetic liners.Study design:Systematic review.Methods:A comprehensive suite of databases were searched using terms related to amputation level, liner type and user experience. Included studies were in English and measured the first-person experience of using a transtibial liner. Studies were appraised using the McMaster University Critical Review Forms.Results:A total of 18 articles met the inclusion criteria. While the quality of the evidence has improved over time, a number of common issues (e.g. sampling bias, validity of outcome measures, incorrect inferential analysis) reduce our ability to differentiate between the user experience of different transtibial liners.Conclusion:There is insufficient research to differentiate between the user experience of different transtibial liners. High-quality research is needed to inform decisions about liner prescription based on the user experience.Clinical relevanceThe available evidence suggests that the user experience of commonly reported problems (e.g. sweating) may be very similar between different liners. Aspects of the user experience that differ most between liners (e.g. unwanted noises, rotation within the socket) can help focus attention on what matters most when discussing prescription.

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SWE and SMI Ultrasound Techniques for Monitoring Needling Treatment of Ankylosing Spondylitis: Study Protocol for a Single-blinded Randomized Controlled Trial

10.21203/rs.3.rs-354903/v1 ◽

2021 ◽

Author(s):

Mengyu Wang ◽

Wen Fu ◽

Lingcui Meng ◽

Jiajia Liu ◽

Lihua Wu ◽

...

Keyword(s):

Quality Of Life ◽

Blood Flow ◽

Ankylosing Spondylitis ◽

Outcome Measures ◽

Healthy Subjects ◽

Acupuncture Group ◽

Musculoskeletal Ultrasound ◽

Sham Control ◽

Post Intervention

Abstract Background: Ankylosing spondylitis (AS) is a high-incidence disease in young men that interferes with patients’ physical and mental wellbeing and overall quality of life (QoL) (7). It is often accompanied by arthralgia, stiffness and limited lumbar flexibility. Acupuncture is safe and effective for reducing the symptoms of AS, but the underlying mechanisms by which it does so are not fully understood. Therefore, to objectively assess acupuncture efficacy, which is critical for patients making informed decisions about appropriate treatments, we will use shear-wave elastography (SWE) and superb microvascular imaging (SMI) ultrasound techniques to evaluate elasticity of lumbar paraspinal muscles and blood flow to the sacroiliac joint (SIJ) in AS.Methods: We will recruit a total of 70 participants diagnosed with AS and 30 healthy subjects. Participants will be randomly allocated 1:1 to either an acupuncture group or a sham control acupuncture group. Primary-outcome measures will be musculoskeletal ultrasound and the Bath Ankylosing Spondylitis Metrology Index (BASMI). Secondary-outcome measures will be the Ankylosing Spondylitis Quality of Life Scale (ASQoL), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Function Index (BASFI), Fatigue Scale-14 (FS-14), Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS). We will monitor the effect of acupuncture or sham acupuncture on blood flow and SIJ inflammation using SMI, lumbar-muscle stiffness using SWE and the lumbar paraspinal-muscle cross-sectional area (CSA) using two-dimensional (2D) grayscale imaging. QoL, physical function and fatigue will be assessed using an evaluation scale or questionnaire developed for this study, with outcomes measured by the ASQoL, BASMI, BASDAI, BASFI and FS-14. Mental state will be evaluated using the SAS and SDS. Healthy subjects will not receive acupuncture but undergo only musculoskeletal ultrasound at baseline. Acupuncture and sham control acupuncture interventions will be conducted for 30 min, 2–3 times/week for 12 weeks. Musculoskeletal ultrasound will be conducted at baseline and post-intervention, while other outcomes will be measured at baseline, 6 weeks and post-intervention. The statistician, outcome assessor and participants will be blinded to treatment allocation.Discussion: The results of this single-blinded, randomized trial with sham controls could help demonstrate the efficacy of acupuncture and clarify whether musculoskeletal ultrasound could be used to evaluate AS.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000031476. Registered April 3, 2020. http://www.chictr.org.cn/index.aspx.

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The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine: A Study Protocol for a Randomized Controlled Trial

Frontiers in Neurology ◽

10.3389/fneur.2021.709803 ◽

2021 ◽

Vol 12 ◽

Author(s):

Tianye Hu ◽

Hantong Hu ◽

Feng Chen ◽

Bin Jiang ◽

Fengfei Shen ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Outcome Measures ◽

Vestibular Migraine ◽

Secondary Outcome ◽

Control Group ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Randomized Controlled

Introduction: With a high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect the quality of life of patients, but it remains difficult to manage by current treatment options. Acupuncture may be a potential treatment option for VM prophylaxis, but the currently available evidence is still uncertain. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for VM prophylaxis.Methods: This is a 28-week parallel, randomized, controlled clinical trial including 4 weeks of baseline, 8 weeks of treatment, and 16 weeks of follow-up. A total of 72 participants will be randomly assigned to two groups. The participants will receive acupuncture in the experimental group, while the participants in the control group will be treated with venlafaxine. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in doses of rescue medication, anxiety level, depression level, and quality of life per 4 weeks from baseline. Adverse events will be recorded for safety evaluation.Discussion: This study will investigate the efficacy and safety of acupuncture for VM prophylaxis. The results will contribute to determining whether acupuncture can serve as an optional treatment strategy for treating VM.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT0464088.

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Acupuncture for Comorbid Mild-Moderate Depression and Chronic Musculoskeletal Pain: Study Protocol for A Randomized Controlled Trial

10.21203/rs.3.rs-67828/v1 ◽

2021 ◽

Author(s):

sheng Li ◽

Jing Liu ◽

Jianpeng Huang ◽

Ding Luo ◽

Qian Wu ◽

...

Keyword(s):

Quality Of Life ◽

Effective Treatment ◽

Musculoskeletal Pain ◽

Outcome Measures ◽

Controlled Trial ◽

Sham Acupuncture ◽

Chronic Musculoskeletal Pain ◽

World Health ◽

Secondary Outcome

Abstract Background: Depression and Chronic musculoskeletal pain (CMSP) are the leading causes of global years lived with disability diseases. Moreover, they often commonly coexist, which made a great difficult to diagnosis and treatment. A safe and effective treatment was urgently need. Previous studies showed that acupuncture was a cost-effective treatment for simple depression or CMSP. But limited evidence showed that acupuncture was effective for depression comorbid CMSP. Methods: This is a randomized, sham acupuncture-controlled trial with three arms: real acupuncture (RA), sham acupuncture (SA) and healthy control (HC). 48 depression combined CMSP participants and 12 healthy people will be recruited from GDTCM hospital and randomized 2:2:1 to RA, SA, HC group. The patients will receive RA or SA intervention for 8 weeks, and HC will not receive any intervention. Upon completion of the intervention, there is a 4 weeks follow-up. The primary outcome measures will be severity of depression and pain which assessed by Hamilton depression rating scale (HAMD-17) and brief pain inventory (BPI), respectively. The secondary outcome measures will be cognitive function, and quality of life which measured by Montreal cognitive assessment (MoCA), P300 and world health organization quality of life (WHOQOL-BREF). In addition, the correlation between brain derived neurotrophic factor (BDNF) and symptoms will also be determined. Discussion: The aim of this study is to evaluate the clinic efficacy and underlying mechanism of acupuncture on depression comorbid CMSP. This study will provide a convenient and cost-effectively means for future prevention and treatment of combined depression and CMSP.Trial registration: This study pre-registered at 2th Feb 2018, at Chinese Clinical Trail Registry (ChiCTR1800014754). The study is on the recruiting status.

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