Efficacy of contralaterally controlled functional electrical stimulation compared to cyclic neuromuscular electrical stimulation and task-oriented training for recovery of hand function after stroke: study protocol for a multi-site randomized controlled trial.

BACKGROUND: Multi-site studies in stroke rehabilitation are important for determining whether a technology and/or treatment can be successfully administered by sites other than the originating site and with similar positive outcomes. This study is the first multi-site clinical trial of a novel intervention for post-stroke upper limb rehabilitation called contralaterally controlled functional electrical stimulation (CCFES). Previous pilot and single-site studies showed positive effects of CCFES on upper limb impairment and hand dexterity in stroke survivors. The main purpose of this study is to confirm and demonstrate the efficacy of CCFES in a larger group of most likely responders across multiple clinical sites. METHODS: Up to 129 stroke survivors with moderate to severe upper extremity hemiparesis at 4 clinical trial sites will be randomized to CCFES, cyclic neuromuscular electrical stimulation (cNMES), or task-oriented-training (TOT). Participants will receive 12 weeks of group-specific therapy. Blinded assessments of upper limb impairment and activity limitation, quality of life, and neurophysiology will be used to compare outcomes at baseline, after treatment, and up to 6 months post-treatment. The primary endpoint is change in dexterity from baseline to 6 months post-treatment. DISCUSSION: Loss of hand function following stroke is a major rehabilitation problem affecting millions of people per year globally. More effective rehabilitation therapies are needed to restore hand function in these individuals. This study will determine whether CCFES therapy produces greater improvements in upper extremity function than cNMES or TOT, and will begin to elucidate the different mechanisms underlying each of the three treatments. This multi-site study is a critical step in advancing a novel method of rehabilitation toward clinical translation and widespread dissemination. TRIAL REGISTRATION: ClinicalTrials.gov NCT03574623 . Registered prior to first enrollment; July 2, 2018.

The protocol for a multisite, double blind, randomized, placebo-controlled trial of axillary nerve stimulation for chronic shoulder pain.

BACKGROUND: Shoulder impingement syndrome is one of the most common causes of shoulder pain, accounting for approximately 30% of all shoulder pain. Approximately 35% of patients with shoulder impingement syndrome are refractory to conservative treatment. For patients who fail conservative treatment, there is no established treatment to successfully treat their chronic pain. Prior randomized control trials have demonstrated efficacy for the use of a single lead intramuscular peripheral nerve stimulation of the axillary nerve at the motor points of the deltoid muscle for treatment of hemiplegic shoulder pain. This is the first controlled trial to utilize the same novel technology to treat shoulder impingement syndrome outside of the stroke population. METHODS: This is a dual-site, placebo-controlled, double-blinded, randomized control trial. Participants will be randomized to two treatment groups. The intervention group will be treated with active peripheral nerve stimulation of the axillary nerve of the affected shoulder and the control group will be treated with sham peripheral nerve stimulation of the axillary nerve of the affected shoulder. Both groups will receive a standardized exercise therapy program directed by a licensed therapist. DISCUSSION: This study protocol will allow the investigators to determine if this novel, non-pharmacologic treatment of shoulder pain can demonstrate the same benefit in musculoskeletal patients which has been previously demonstrated in the stroke population. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03752619. Registered on 26 November 2018.

Convergent Validity and Responsiveness of the SULCS.

OBJECTIVE: To evaluate the convergent validity and responsiveness of the Stroke Upper Limb Capacity Scale (SULCS) in comparison to the Arm Motor Ability Test (AMAT), the Box and Blocks Test (BBT), and the upper limb Fugl-Meyer Assessment (FMA). The SULCS is a relatively new measure that was designed to be easier to score and less time consuming than some existing measures. DESIGN: Prospective repeated-measures design. SETTING: Clinical research laboratory of a large public hospital. PARTICIPANTS: Patients (N=61) <2 years poststroke with moderate to severe upper limb hemiparesis. INTERVENTION: Participants received 12 weeks of therapy that included neuromuscular electrical stimulation of the paretic finger and thumb extensors. The SULCS, AMAT, BBT, and FMA were administered at weeks 0, 6, 12 (end of therapy), 20, 28, and 36 (6mo post-therapy). MAIN OUTCOME MEASURES: Convergent validity was evaluated with Spearman's correlation coefficients between pairs of measures at each time point. Responsiveness from 0 to 12 weeks and 0 to 36 weeks was evaluated with the standardized response mean (SRM). RESULTS: The SULCS demonstrated strong correlation with the AMAT (ρ=0.81-0.93), BBT (ρ=0.73-0.92), and FMA (ρ=0.78-0.92), at all 6 time points. All 4 measures had moderate to large SRMs (SULCS, 0.71-0.77; AMAT, 0.83-0.97; BBT, 0.73-0.82; FMA, 0.75-0.76). There was no significant difference in responsiveness among the 4 measures. CONCLUSIONS: The results support the use of the SULCS to measure upper limb capacity in patients who are less than 2 years poststroke with moderate to severe hemiplegia.