Proprioceptive Training with Visual Feedback Improves Upper Limb Function in Stroke Patients: A Pilot Study

Proprioceptive deficit is one of the common sensory impairments following stroke and has a negative impact on motor performance. However, evidence-based training procedures and cost-efficient training setups for patients with poststroke are still limited. We compared the effects of proprioceptive training versus nonspecific sensory stimulation on upper limb proprioception and motor function rehabilitation. In this multicenter, single-blind, randomized controlled trial, 40 participants with poststroke hemiparesis were enrolled from 3 hospitals in China. Participants were assigned randomly to receive proprioceptive training involving passive and active movements with visual feedback (proprioceptive training group [PG]; n = 20 ) or nonspecific sensory stimulation (control group [CG]; n = 20 ) 20 times in four weeks. Each session lasted 30 minutes. A clinical assessor blinded to group assignment evaluated patients before and after the intervention. The primary outcome was the change in the motor subscale of the Fugl-Meyer assessment for upper extremity (FMA-UE-M). Secondary outcomes were changes in box and block test (BBT), thumb localization test (TLT), the sensory subscale of the Fugl-Meyer assessment for upper extremity (FMA-UE-S), and Barthel Index (BI). The results showed that the mean change scores of FMA-UE were significantly greater in the PG than in the CG ( p = 0.010 for FMA-UE-M, p = 0.033 for FMA-UE-S). The PG group was improved significantly in TLT ( p = 0.010 ) and BBT ( p = 0.027 ), while there was no significant improvement in TLT ( p = 0.083 ) and BBT ( p = 0.107 ) for the CG group. The results showed that proprioceptive training was effective in improving proprioception and motor function of the upper extremity in patients with poststroke. This trial is registered in the Chinese Clinical Trial Registry (ChiCTR2000037808).

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Reinforced Feedback in Virtual Environment for Rehabilitation of Upper Extremity Dysfunction after Stroke: Preliminary Data from a Randomized Controlled Trial

BioMed Research International ◽

10.1155/2014/752128 ◽

2014 ◽

Vol 2014 ◽

pp. 1-8 ◽

Cited By ~ 45

Author(s):

Paweł Kiper ◽

Michela Agostini ◽

Carlos Luque-Moreno ◽

Paolo Tonin ◽

Andrea Turolla

Keyword(s):

Randomized Controlled Trial ◽

Virtual Environment ◽

Upper Extremity ◽

Motor Function ◽

Upper Limb ◽

Controlled Trial ◽

Functional Independence Measure ◽

Functional Independence ◽

Stroke Etiology ◽

Randomized Controlled

Objectives. To study whether the reinforced feedback in virtual environment (RFVE) is more effective than traditional rehabilitation (TR) for the treatment of upper limb motor function after stroke, regardless of stroke etiology (i.e., ischemic, hemorrhagic).Design. Randomized controlled trial.Participants. Forty-four patients affected by stroke.Intervention. The patients were randomized into two groups: RFVE (N=23) and TR (N=21), and stratified according to stroke etiology. The RFVE treatment consisted of multidirectional exercises providing augmented feedback provided by virtual reality, while in the TR treatment the same exercises were provided without augmented feedbacks.Outcome Measures. Fugl-Meyer upper extremity scale (F-M UE), Functional Independence Measure scale (FIM), and kinematics parameters (speed, time, and peak).Results. The F-M UE (P=0.030), FIM (P=0.021), time (P=0.008), and peak (P=0.018), were significantly higher in the RFVE group after treatment, but not speed (P=0.140). The patients affected by hemorrhagic stroke significantly improved FIM (P=0.031), time (P=0.011), and peak (P=0.020) after treatment, whereas the patients affected by ischemic stroke improved significantly only speed (P=0.005) when treated by RFVE.Conclusion. These results indicated that some poststroke patients may benefit from RFVE program for the recovery of upper limb motor function. This trial is registered withNCT01955291.

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Assessment of virtual teacher feedback for the recovery of the upper limb after a stroke. Study protocol for a randomized controlled trial.

Rehabilitacja Medyczna ◽

10.5604/01.3001.0009.5010 ◽

2016 ◽

Vol 20 (3) ◽

pp. 13-20 ◽

Cited By ~ 1

Author(s):

Pawel Kiper ◽

Carla Zucconi ◽

Michela Agostini ◽

Alfonc Baba ◽

Francesco Dipalma ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Virtual Reality ◽

Motor Function ◽

Visual Feedback ◽

Study Protocol ◽

Upper Limb ◽

Controlled Trial ◽

Teacher Feedback ◽

Randomized Controlled ◽

Stroke Study

Enhanced feedback provided by virtual reality has been shown to promote motor learning both in healthy subjects and patients with motor impairments following lesions of the central nervous system. The aim of this study is to evaluate the effect of displaying a virtual teacher as visual feedback to promote the recovery of upper limb motor function after a stroke. The protocol reports the design of a single blind randomized controlled trial (RCT), blinded to outcome assessment. Two different treatments based on virtual reality will be compared: in the “Teacher” group, the patients receive treatment with continuous displaying of a virtual teacher, while in the “No-Teacher” group, the same exercises will be proposed without visualization of a virtual teacher. The Fugl-Meyer upper extremity scale will be considered as the primary outcome, while the Functional Independence Measure scale, Reaching Performance Scale and Modified Ashworth Scale will be considered as secondary outcomes. Moreover, kinematic parameters such as mean duration (seconds), mean linear velocity (cm/s) and smoothness (i.e. number of sub-movements) will be registered when performing standardised tasks. All tests will be performed before and after treatments. Both treatments will last four weeks with a daily session lasting one hour, five days a week (20 overall sessions). This study is designed to systematically assess the influence of using enhanced visual feedback for the recovery of upper limb motor function after a stroke. These findings will help to determine whether the use of a virtual teacher as enhanced visual feedback is effective for promoting better recovery of upper limb motor function over four weeks of post-stroke treatment. Current Controlled Trials registration number: NCT02234531 (registered on 29 August 2014, ClinicalTrials. gov) Kiper P., Zucconi C., Agostini M., Baba A., Dipalma F., Berlingieri C., Longhi C., Tonin P., Turolla A. Assessment of virtual teacher feedback for the recovery of the upper limb after a stroke. Study protocol for a randomized controlled trial. Med Rehabil 2016; 20(3): 13-20. DOI: 10.5604/01.3001.0009.5010

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Restoration of Upper Limb Motor Function After Stroke

Journal of restorative medicine and rehabilitation ◽

10.38025/2078-1962-2021-20-1-21-26 ◽

2021 ◽

Vol 20 (1) ◽

pp. 21-26

Author(s):

Elena V. Kayerova ◽

Natalya S. Zhuravskaya ◽

Ekaterina A. Kozina ◽

Olga V. Shakirova

Keyword(s):

Muscle Strength ◽

Upper Extremity ◽

Motor Function ◽

Upper Limb ◽

Recovery Period ◽

Early Period ◽

Control Group ◽

Physical Culture ◽

Biological Feedback ◽

Early Recovery

Since the task of eliminating the consequences of a stroke remains unsolved, research on the use of robotic simulators equipped with feedback to restore upper limb motor functions is of particular relevance. Aim of the study was to conduct an experimental evaluation of the effectiveness of the use of the Anika sensory glove with biological feedback for the restoration of upper extremity motor function in the early period of ischemic stroke. Materials and methods. We analyzed 108 medical histories and selected 28 patients with a single history of stroke and moderate cognitive disorders, which were divided into 2 groups - control and experimental with 14 individuals each. Patients of the control group engaged in therapeutic physical culture according to the traditional methodology adopted in neurological practice and aimed at restoring muscle strength, passive and active movements of the upper extremity. Trainings using the sensory glove Anika with biological feedback were included in the therapeutic physical culture training program for the experimental group. Results. The inclusion of special exercises on the Anika simulator with biological feedback in a comprehensive physical rehabilitation program increases the effectiveness of the recovery process, contributing to improving articular mobility, reducing spasticity, increasing muscle strength of the hand, reducing the level of personal and situational anxiety, normalizing psychoemotional state and increasing the functional mobility of stroke patients. Conclusion. The use of the sensory glove Anika with biological feedback in the early recovery period contributed to the expansion of the motor activity of patients, the development of self-care skills, psychological and social adaptation.

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Action Observation Treatment-Based Exoskeleton (AOT-EXO) for Upper Extremity After Stroke: Study Protocol for a Randomised Controlled Trial

10.21203/rs.3.rs-58170/v1 ◽

2021 ◽

Author(s):

Zejian Chen ◽

Nan Xia ◽

Chang He ◽

Minghui Gu ◽

Jiang Xu ◽

...

Keyword(s):

Upper Extremity ◽

Functional Disability ◽

Motor Evoked Potentials ◽

Action Observation ◽

Controlled Trial ◽

Measurement Unit ◽

Motor Deficit ◽

Robot Assisted ◽

Clinical Trial Registry ◽

Resting Motor Threshold

Abstract Background Stroke produces multiple symptoms, including sensory, motor, cognitive and psychological dysfunctions, among which motor deficit is the most common and is widely recognized as a major contributor to long-term functional disability. Robot-assisted training is effective in promoting upper extremity muscle strength and motor impairment recovery after stroke. Additionally, action observation treatment can enhance the effects of physical and occupational therapy by increasing neural activation. The AOT-EXO trial aims to investigate whether action observation treatment coupled with robot-assisted training could enhance motor circuit activation and improve upper extremity motor outcomes. Methods The AOT-EXO trial is a multicentre, prospective, three-group randomized controlled trial (RCT). We will screen and enrol 132 eligible patients in the trial implemented in the Department of Rehabilitation Medicine of Tongji Hospital, Optical Valley Branch of Tongji Hospital and Hubei Province Hospital of Integrated Chinese & Western Medicine in Wuhan, China. Prior to study participation, written informed consent will be obtained from eligible patients in accordance with the Declaration of Helsinki. The enrolled stroke patients will be randomised to three groups: the CT group (conventional therapy); EXO group (exoskeleton therapy) and AOT-EXO group (action observation treatment-based exoskeleton therapy). The patients will undergo blinded assessments at baseline, post-intervention (after 4 weeks) and follow-up (after 12 weeks). The primary outcome will be the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Secondary outcomes will include the Action Research Arm Test (ARAT), modified Barthel Index (MBI), kinematic metrics assessed by inertial measurement unit (IMU), resting motor threshold (rMT), motor evoked potentials (MEP), functional magnetic resonance imaging (fMRI) and safety outcomes. Discussion This trial will provide evidence regarding the feasibility and efficacy of the action observation treatment-based exoskeleton (AOT-EXO) for post-stroke upper extremity rehabilitation and elucidate the potential underlying kinematic and neurological mechanisms. Trial Registration: Chinese Clinical Trial Registry identifier: ChiCTR1900026656. Registered on 17 October 2019.

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Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: A multicenter, randomized, double-blind, placebo-controlled trial

10.21203/rs.3.rs-16499/v2 ◽

2020 ◽

Author(s):

Jun Ni ◽

Huisheng Chen ◽

Guofang Chen ◽

Yong Ji ◽

Fei Yi ◽

...

Keyword(s):

Ischemic Stroke ◽

Thrombolytic Therapy ◽

Acute Ischemic Stroke ◽

Barthel Index ◽

Controlled Trial ◽

Survival Rates ◽

Control Group ◽

Efficacy And Safety ◽

Clinical Trial Registry ◽

Double Blind

Abstract Background: Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 hours of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.Methods: Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.Results: In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p=0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p=0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.Conclusions: The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.Trial registration: Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827. Retrospectively registered June 13, 2019.

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Enhanced Visual Feedback Using Immersive VR Affects Decision Making Regarding Hand Use With a Simulated Impaired Limb

Frontiers in Human Neuroscience ◽

10.3389/fnhum.2021.677578 ◽

2021 ◽

Vol 15 ◽

Author(s):

Naoko Sakabe ◽

Samirah Altukhaim ◽

Yoshikatsu Hayashi ◽

Takeshi Sakurada ◽

Shiro Yano ◽

...

Keyword(s):

Decision Making ◽

Visual Feedback ◽

Upper Limb ◽

Positive Reinforcement ◽

Motor Coordination ◽

Negative Impact ◽

Dominant Hand ◽

Long Term Effects ◽

Upper Limb Function ◽

Feedback Enhancement

The long-term effects of impairment have a negative impact on the quality of life of stroke patients in terms of not using the affected limb even after some recovery (i.e., learned non-use). Immersive virtual reality (IVR) has been introduced as a new approach for the treatment of stroke rehabilitation. We propose an IVR-based therapeutic approach to incorporate positive reinforcement components in motor coordination as opposed to constraint-induced movement therapy (CIMT). This study aimed to investigate the effect of IVR-reinforced physical therapy that incorporates positive reinforcement components in motor coordination. To simulate affected upper limb function loss in patients, a wrist weight was attached to the dominant hand of participant. Participants were asked to choose their right or left hand to reach toward a randomly allocated target. The movement of the virtual image of the upper limb was reinforced by visual feedback to participants, that is, the participants perceived their motor coordination as if their upper limb was moving to a greater degree than what was occurring in everyday life. We found that the use of the simulated affected limb was increased after the visual feedback enhancement intervention, and importantly, the effect was maintained even after gradual withdrawal of the visual amplification. The results suggest that positive reinforcement within the IVR could induce an effect on decision making in hand usage.

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Auricular acupressure for hot flashes in patients with prostate cancer: protocol for a pilot randomized controlled trial

10.21203/rs.3.rs-27959/v1 ◽

2020 ◽

Author(s):

Jianfu Zhou ◽

Rongwu Lin ◽

Xuehua Liu ◽

Liguo Lv ◽

Shusheng Wang ◽

...

Keyword(s):

Prostate Cancer ◽

Pilot Study ◽

Controlled Trial ◽

Hot Flashes ◽

Preliminary Evidence ◽

Control Group ◽

Random Allocation ◽

Clinical Trial Registry ◽

Auricular Acupressure

Abstract BackgroundHot flashes, characterized by intense heat sensation and diaphoresis, are common side effects resulted from hormonotherapy in patients with prostate cancer. Cumulated studies have revealed beneficial role of acupuncture as complementary and alternative recipe for the management of hot flashes. However, little is known about the auricular acupressure (AA), a micro-acupuncture technique whose therapeutic purpose is similar with conventional acupuncture. Therefore, this current study aims to explore the effects and determine the feasibility of AA for hot flashes in patients with prostate cancer.Methods/DesignThis proposed pilot study is a two-arm parallel, single-blinded, randomized sham-controlled trial. A total of 72 participants of prostate cancer suffered with hot flashes will be recruited and randomly allocated into two groups in a 1:1 ratio. Equal randomization is conducted using a computer-generated random allocation sequence. Sheng Zhi Qi (TF2), Nei Fen Mi (CO18), Shen Men (TF4), Shen (CO10) and Pi Zhi Xia (AT4) are selected as experimental acupressure points, and five helix points (HX 8-12) are used as sham control acupressure points. Participants in the experimental group and control group will receive AA and sham-AA treatment, respectively. The duration of the treatment is 6 weeks with two sessions per week, and the follow-up period is 12 weeks. The primary outcome is Hot Flash Score (HFS). The secondary outcomes include Quality of Life (QoL), Pittsburgh Sleep Quality Index (PSQI) and Hamilton Anxiety Scale (HAS). All outcomes measurement will be conducted before and through treatment period as well as follow-up period. Safety assessment will be carried out through treatment and follow-up period.DiscussionThis pilot study will for the first time advance our knowledge on feasibility of AA in alleviating hot flashes in patients of prostate cancer and provide preliminary evidence for a further full-scale trial.Trial registrationChinese Clinical Trial Registry, ChiCTR1900026694. Registered on 19 October 2019.

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A Proposal of an innovative program for informal caregivers of patients with mood disorders

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.943 ◽

2017 ◽

Vol 41 (S1) ◽

pp. S603-S603

Author(s):

J. Cabral ◽

C. Barreto Carvalho ◽

P. Castilho Freitas ◽

C. Pato

Keyword(s):

Quality Of Life ◽

Mood Disorders ◽

Negative Impact ◽

Controlled Trial ◽

Informal Caregivers ◽

Well Being ◽

Control Group ◽

Compassion Focused Therapy ◽

The Impact

IntroductionIntervention with informal caregivers (IC) of psychiatric patients is internationally recognized as relevant and a priority. However, the existing responses in this area are still insufficient, especially regarding caregivers of individuals with mood disorders (MD). Mindfulness and compassion focused therapy have proven to be an effective approach in stress reduction and in improving emotional and social well-being of caregivers of patients with other conditions. However, no studies testing these new approaches in IC of patients with MD have been carried out. The objective of this work is to present a research project that aims to develop, implement and empirically test the effectiveness of an innovative group program to help informal caregivers of individuals with mood disorders to cope with the negative impact of the disease and reduce caregiver burdens.MethodsThe design of this experimental study to test the program's efficacy is a non-randomised controlled trial (nrct) with 12 months follow-up, with a mixed assessment methodology (quantitative and qualitative analysis). A sample of 60 informal caregivers of individuals with chronic MD will be constituted (n = 30 Control group; n= 30 Experimental group).ResultsWe expect the program to promote significant changes in participants in terms of several emotional variables (eg: burden, stress, resilience, compassion and quality of life).ConclusionsFurther efforts to continue studying the impact of interventions in caregivers should be carried out, as a way to improve the quality of life of caregivers and their ability to provide informal care to MD patients.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol

BMJ Open ◽

10.1136/bmjopen-2019-032799 ◽

2019 ◽

Vol 9 (10) ◽

pp. e032799 ◽

Cited By ~ 1

Author(s):

Titus Beyuo ◽

Emma Lawrence ◽

Elizabeth S Langen ◽

Samuel A Oppong

Keyword(s):

Randomised Controlled Trial ◽

Health Outcomes ◽

Magnesium Sulfate ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

University Of Michigan ◽

Clinical Trial Registry ◽

Randomised Controlled ◽

Study Participants

IntroductionHypertensive disorders of pregnancy continue to be a major contributor to maternal and perinatal morbidity and mortality. Magnesium sulfate therapy is the standard of care for seizure prophylaxis and treatment for pre-eclampsia and eclampsia respectively, despite wide disparities in dosing regimens and routes of administration. This study compares the clinical efficacy of magnesium sulfate in the reduction of seizure occurrence or recurrence with the 12 hours versus 24 hours modified Pritchard regimens in the management of severe pre-eclampsia and eclampsia.Methods and analysisThis study is an open labelled randomised controlled trial. The study participants are patients admitted to the Korle Bu Teaching Hospital (KBTH) in Accra, Ghana with a diagnosis of antepartum, intrapartum or postpartum eclampsia or pre-eclampsia with severe features. All study participants will be administered a loading dose of magnesium sulfate, followed by maintenance dosing. Participants in the control group will receive magnesium sulfate for 24 hours after diagnosis, while those in the treatment group will receive magnesium sulfate for 12 hours after diagnosis. The primary outcome of this study is the occurrence of a seizure any time after the completion of treatment in the assigned group. Secondary outcome measures include maternal health outcomes, magnesium sulfate toxicities and fetal health outcomes. Data collection was started in October 2018 with a target enrolment of 1245 participants with severe pre-eclampsia and 844 participants with eclampsia with a projected study period of 2–3 years.Ethics and disseminationEthical approval was obtained from the KBTH Institutional Review Board (IRB) in Ghana. University of Michigan involvement is limited to protocol development and statistical analysis of de-identified data, and has been granted a Not Regulated Determination by the University of Michigan IRB. Results of the study will be shared at clinical forums at the KBTH and will be submitted for publication in an international peer-reviewed journal.Trial registration numberPan African Clinical Trial Registry through the South African Medical Research Council (PACTR201811515303983).

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Sensor-based technology for upper limb rehabilitation in patients with multiple sclerosis: A randomized controlled trial

Restorative Neurology and Neuroscience ◽

10.3233/rnn-201033 ◽

2020 ◽

Vol 38 (4) ◽

pp. 333-341

Author(s):

Marco Tramontano ◽

Giovanni Morone ◽

Sara De Angelis ◽

Laura Casagrande Conti ◽

Giovanni Galeoto ◽

...

Keyword(s):

Multiple Sclerosis ◽

Upper Limb ◽

Controlled Trial ◽

Control Group ◽

Hand Rehabilitation ◽

Upper Limb Rehabilitation ◽

Rehabilitation Programs ◽

Scale Scores ◽

Limb Rehabilitation ◽

Experimental Group

Background: Sensor-based technological therapy devices may be good candidates for neuromotor rehabilitation of people with Multiple Sclerosis (MS), especially for treating upper extremities function limitations. The sensor-based device rehabilitation is characterized by interactive therapy games with audio-visual feedback that allows training the movement of shoulders, elbows, and wrist, measuring the strength and the active range of motion of upper limb, registering data in an electronic database to quantitatively monitoring measures and therapy progress. Objective: This study aimed to investigate the effects of sensor-based motor rehabilitation in add-on to the conventional neurorehabilitation, on increasing the upper limb functions of patients with MS. Methods: Thirty patients were enrolled in the study and randomly assigned to the experimental group and the control group. The training consisting of twelve sessions of upper limb training was compared with twelve sessions of upper limb sensory-motor training, without robotic support. Both rehabilitation programs were performed for 40 minutes three times a week, for 4 weeks, in addition to conventional therapy. All patients were evaluated at the baseline (T0) and after 4 weeks of training (T1). Results: The within-subject analysis showed a statistically significant improvement in both groups, in the Modified Barthel Index and in the Rivermead Mobility Index scores and a significant improvement in Multiple Sclerosis Quality of Life-54 in the experimental. The analysis of effectiveness revealed that, compared with baseline (T0), the improvement percentage in all clinical scale scores was greater in the experimental group than the control group. Conclusions: Proposed training provides an intensive and functional-oriented rehabilitation that objectively evaluates achieved progress through exercises. Therefore, it can represent a good complementary strategy for hand rehabilitation in MS patients.

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