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Functional rehabilitation of upper limb apraxia in poststroke patients: study protocol for a randomized controlled trial.

ABSTRACT: Upper limb apraxia is a common disorder associated with stroke that can reduce patients' independence levels in activities of daily living and increase levels of disability. Traditional rehabilitation programs designed to promote the recovery of upper limb function have mainly focused on restorative or compensatory approaches. However, no previous studies have been completed that evaluate a combined intervention method approach, where patients concurrently receive cognitive training and learn compensatory strategies for enhancing daily living activities.This study will use a two-arm, assessor-blinded, parallel, randomized controlled trial design, involving 40 patients who present a left- or right-sided unilateral vascular lesion poststroke and a clinical diagnosis of upper limb apraxia. Participants will be randomized to either a combined functional rehabilitation or a traditional health education group. The experimental group will receive an 8-week combined functional program at home, including physical and occupational therapy focused on restorative and compensatory techniques for upper limb apraxia, 3 days per week in 30-min intervention periods. The control group will receive a conventional health education program once a month over 8 weeks, based on improving awareness of physical and functional limitations and facilitating the adaptation of patients to the home. Study outcomes will be assessed immediately postintervention and at the 2-month follow-up. The primary outcome measure will be basic activities of daily living skills as assessed with the Barthel Index. Secondary outcome measures will include the following: 1) the Lawton and Brody Instrumental Activities of Daily Living Scale, 2) the Observation and Scoring of ADL-Activities, 3) the De Renzi Test for Ideational Apraxia, 4) the De Renzi Test for Ideomotor Apraxia, 5) Recognition of Gestures, 6) the Test of Upper Limb Apraxia (TULIA), and 7) the Quality of Life Scale For Stroke (ECVI-38).This trial is expected to clarify the effectiveness of a combined functional rehabilitation approach compared to a conservative intervention for improving upper limb movement and function in poststroke patients.Clinical Trial Gov number NCT02199093 . The protocol registration was received 23 July 2014. Participant enrollment began on 1 May 2014. The trial is expected to be completed in March 2016.

SUBMITTER: Perez-Marmol JM

PROVIDER: S-EPMC4636071 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Functional rehabilitation of upper limb apraxia in poststroke patients: study protocol for a randomized controlled trial.

Pérez-Mármol Jose Manuel JM García-Ríos M Carmen MC Barrero-Hernandez Francisco J FJ Molina-Torres Guadalupe G Brown Ted T Aguilar-Ferrándiz María Encarnación ME

Trials 20151105

<h4>Background</h4>Upper limb apraxia is a common disorder associated with stroke that can reduce patients' independence levels in activities of daily living and increase levels of disability. Traditional rehabilitation programs designed to promote the recovery of upper limb function have mainly focused on restorative or compensatory approaches. However, no previous studies have been completed that evaluate a combined intervention method approach, where patients concurrently receive cognitive tr ...[more]

PMID: 26542104

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Project description:BACKGROUND:Many stroke survivors suffer from sensory impairments of their affected upper limb (UL). Although such impairments can affect the ability to use the UL in everyday activities, very little attention is paid to sensory impairments in stroke rehabilitation. The purpose of this trial is to investigate if sensory re-learning in combination with task-specific training may prove to be more effective than task-specific training alone to improve sensory function of the hand, dexterity, the ability to use the hand in daily activities, perceived participation, and life satisfaction. METHODS/DESIGN:This study is a single-blinded pilot randomized controlled trial (RCT) with two treatment arms. The participants will be randomly assigned either to sensory re-learning in combination with task-specific training (sensory group) or to task-specific training only (control group). The training will consist of 2.5 h of group training per session, 2 times per week for 5 weeks. The primary outcome measures to assess sensory function are as follows: Semmes-Weinstein monofilament, Shape/Texture Identification (STI™) test, Fugl-Meyer Assessment-upper extremity (FMA-UE; sensory section), and tactile object identification test. The secondary outcome measures to assess motor function are as follows: Box and Block Test (BBT), mini Sollerman Hand Function Test (mSHFT), Modified Motor Assessment Scale (M-MAS), and Grippit. To assess the ability to use the hand in daily activities, perceived participation, and life satisfaction, the Motor Activity Log (MAL), Canadian Occupational Performance Measure (COPM), Stroke Impact Scale (SIS) participation domain, and Life Satisfaction checklist will be used. Assessments will be performed pre- and post-training and at 3-month follow-up by independent assessors, who are blinded to the participants' group allocation. At the 3-month follow-up, the participants in the sensory group will also be interviewed about their general experience of the training and how effective they perceived the training. DISCUSSION:The results from this study can add new knowledge about the effectiveness of sensory re-learning in combination with task-specific training on UL functioning after stroke. If the new training approach proves efficient, the results can provide information on how to design a larger RCT in the future in persons with sensory impairments of the UL after stroke. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03336749 . Registered on 8 November 2017.

Project description:The coracoid approach is recognized as the simplest approach to perform brachial plexus anaesthesia, but needle visualization needs to be improved. With a different needle entry point, the retroclavicular approach confers a perpendicular angle between the ultrasound and the needle, which theoretically enhances needle visualization. This trial compares these two techniques. The leading hypothesis is that the retroclavicular approach is comparable to the infraclavicular coracoid approach in general aspects, but needle visualization is better with this novel approach.We designed a multicentre, randomized, non-inferiority trial. Patients eligible for the study are older than 18 years, able to consent, will undergo urgent or elective upper limb surgery distal to the elbow and are classified with American Society of Anaesthesiologists risk score (ASA) I-III. They will be excluded if they meet contraindicated criteria to regional anaesthesia, have affected anatomy of the clavicle or are pregnant. Randomization will be done by a computer-generated randomization schedule stratified for each site and in 1:1 ratio, and concealment will be maintained with opaque, sealed envelopes in a locked office. The primary outcome, the performance time, will be analyzed using non-inferiority analysis while secondary outcomes will be analyzed with superiority analysis. Needle visualization will be ranked on a Likert scale of 1-5 that is subjective and represents a pitfall. Two separate persons will rank needle visualization to compensate this pitfall. According to previous studies, 49 patients per group are required for statistical power of 0.90 and one-sided type I error of 0.05.The conduct of this study will bring clear answers to our questions and, if our hypothesis is confirmed, will confer an anatomic alternative to difficult coracoid infraclavicular brachial blocks or could even become a standard for brachial plexus anaesthesia.ClinicalTrials.gov, NCT02913625 . Registered on 12 September 2016.

Project description:BackgroundDifferent mechanical supporting strategies to the joints in the upper extremity (UE) may lead to varied rehabilitative effects after stroke. This study compared the rehabilitation effectiveness achieved by electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-robotic systems when supporting to the distal fingers and to the proximal (wrist-elbow) joints.MethodsThirty subjects with chronic stroke were randomly assigned to receive motor trainings with NMES-robotic support to the finger joints (hand group, n = 15) and with support to the wrist-elbow joints (sleeve group, n = 15). The training effects were evaluated by the clinical scores of Fugl-Meyer Assessment (FMA), Action Research Arm Test (ARAT), and Modified Ashworth Scale (MAS) before and after the trainings, as well as 3 months later. The cross-session EMG monitoring of EMG activation level and co-contraction index (CI) were also applied to investigate the recovery progress of muscle activations and muscle coordination patterns through the training sessions.ResultsSignificant improvements (P < 0.05) in FMA full score, FMA shoulder/elbow (FMA-SE) and ARAT scores were found in both groups, whereas significant improvements (P < 0.05) in FMA wrist/hand (FMA-WH) and MAS scores were only observed in the hand group. Significant decrease of EMG activation levels (P < 0.05) of UE flexors was observed in both groups. Significant decrease in CI values (P < 0.05) was observed in both groups in the muscle pairs of biceps brachii and triceps brachii (BIC&TRI) and the wrist-finger flexors (flexor carpi radialis-flexor digitorum) and TRI (FCR-FD&TRI). The EMG activation levels and CIs of the hand group exhibited faster reductions across the training sessions than the sleeve group (P < 0.05).ConclusionsRobotic supports to either the distal fingers or the proximal elbow-wrist could achieve motor improvements in UE. The robotic support directly to the distal fingers was more effective than to the proximal parts in improving finger motor functions and in releasing muscle spasticity in the whole UE.Clinical trial registrationClinicalTrials.gov , identifier NCT02117089; date of registration: April 10, 2014. https://clinicaltrials.gov/ct2/show/NCT02117089.

Dataset Information

Functional rehabilitation of upper limb apraxia in poststroke patients: study protocol for a randomized controlled trial.

Publications

Functional rehabilitation of upper limb apraxia in poststroke patients: study protocol for a randomized controlled trial.

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