Additional early active repetitive motor training did not prevent contracture in adults receiving task-specific upper limb training after stroke: a randomised trial.

QUESTION: In adults undergoing rehabilitation after stroke, does 1 hour of additional active repetitive reaching per day prevent or reduce upper limb contracture? DESIGN: Multi-centre, randomised controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis. PARTICIPANTS: Fifty adults undergoing rehabilitation after stroke who were unable to actively extend the affected wrist past neutral or were unable to flex the affected shoulder to 90 deg. SETTING: Three inpatient rehabilitation units in Australia. INTERVENTION: Both groups received usual upper limb therapy 5 days a week for 5 weeks. In addition, the experimental group received up to 1 hour a day of active, intensive, repetitive upper limb training using the SMART Arm device 5 days a week for 5 weeks. OUTCOME MEASURES: Measures were collected at baseline (Week 0), after intervention (Week 5) and at follow-up (Week 7). The primary outcomes were passive range of wrist extension, elbow extension, and shoulder flexion at Week 5. The secondary outcomes were: the three primary outcomes measured at Week 7; passive range of shoulder external rotation; arm function; and pain at rest, on movement and during sleep measured at Weeks 5 and 7. RESULTS: Following an average of 2310 reaching repetitions, the mean effect at Week 5 on passive range of wrist extension was 1 deg (95% CI -6 to 8), elbow extension -6 deg (95% CI -12 to -1), and shoulder flexion 5 deg (95% CI -8 to 17). There were no statistically significant or clinically important effects of the intervention on any secondary outcomes. CONCLUSION: In adults who are already receiving task-specific motor training for upper limb rehabilitation following stroke, 5 weeks of up to 1 hour of additional daily active repetitive motor training using the SMART Arm device did not prevent or reduce contracture in upper limb muscles. TRIAL REGISTRATION: ACTRN12614001162606.

SMART Arm Training With Outcome-Triggered Electrical Stimulation in Subacute Stroke Survivors With Severe Arm Disability: A Randomized Controlled Trial.

BACKGROUND: Stroke survivors with severe upper limb disability need opportunities to engage in task-oriented practice to achieve meaningful recovery. OBJECTIVE: To compare the effect of SMART Arm training, with or without outcome-triggered electrical stimulation to usual therapy, on arm function for stroke survivors with severe upper limb disability undergoing inpatient rehabilitation. METHODS: A prospective, multicenter, randomized controlled trial was conducted with 3 parallel groups, concealed allocation, assessor blinding and intention-to-treat analysis. Fifty inpatients within 4 months of stroke with severe upper limb disability were randomly allocated to 60 min/d, 5 days a week for 4 weeks of (1) SMART Arm with outcome-triggered electrical stimulation and usual therapy, (2) SMART Arm alone and usual therapy, or (3) usual therapy. Assessment occurred at baseline (0 weeks), posttraining (4 weeks), and follow-up (26 and 52 weeks). The primary outcome measure was Motor Assessment Scale item 6 (MAS6) at posttraining. RESULTS: All groups demonstrated a statistically ( P < .001) and clinically significant improvement in arm function at posttraining (MAS6 change ≥1 point) and at 52 weeks (MAS6 change ≥2 points). There were no differences in improvement in arm function between groups (P = .367). There were greater odds of a higher MAS6 score in SMART Arm groups as compared with usual therapy alone posttraining (SMART Arm stimulation generalized odds ratio [GenOR] = 1.47, 95%CI = 1.23-1.71) and at 26 weeks (SMART Arm alone GenOR = 1.31, 95% CI = 1.05-1.57). CONCLUSION: SMART Arm training supported a clinically significant improvement in arm function, which was similar to usual therapy. All groups maintained gains at 12 months.

Repetitive reaching training combined with transcranial Random Noise Stimulation in stroke survivors with chronic and severe arm paresis is feasible: a pilot, triple-blind, randomised case series.

BACKGROUND: Therapy that combines repetitive training with non-invasive brain stimulation is a potential avenue to enhance upper limb recovery after stroke. This study aimed to investigate the feasibility of transcranial Random Noise Stimulation (tRNS), timed to coincide with the generation of voluntary motor commands, during reaching training. METHODS: A triple-blind pilot RCT was completed. Four stroke survivors with chronic (6-months to 5-years) and severe arm paresis, not taking any medications that had the potential to alter cortical excitability, and no contraindications to tRNS or MRI were recruited. Participants were randomly allocated to 12 sessions of reaching training over 4-weeks with active or sham tRNS delivered over the lesioned hemisphere motor representation. tRNS was triggered to coincide with a voluntary movement attempt, ceasing after 5-s. At this point, peripheral nerve stimulation enabled full range reaching. To determine feasibility, we considered adverse events, training outcomes, clinical outcomes, corticospinal tract (CST) structural integrity, and reflections on training through in-depth interviews from each individual case. RESULTS: Two participants received active and two sham tRNS. There were no adverse events. All training sessions were completed, repetitive practice performed and clinically relevant improvements across motor outcomes demonstrated. The amount of improvement varied across individuals and appeared to be independent of group allocation and CST integrity. CONCLUSION: Reaching training that includes tRNS timed to coincide with generation of voluntary motor commands is feasible. Clinical improvements were possible even in the most severely affected individuals as evidenced by CST integrity. TRIAL REGISTRATION: This study was registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR) http://www.ANZCTR.org.au/ACTRN12614000952640.aspx . Registration date 4 September 2014, first participant date 9 September 2014.

The efficacy of SMART Arm training early after stroke for stroke survivors with severe upper limb disability: a protocol for a randomised controlled trial.

BACKGROUND: Recovery of upper limb function after stroke is poor. The acute to subacute phase after stroke is the optimal time window to promote the recovery of upper limb function. The dose and content of training provided conventionally during this phase is however, unlikely to be adequate to drive functional recovery, especially in the presence of severe motor disability. The current study concerns an approach to address this shortcoming, through evaluation of the SMART Arm, a non-robotic device that enables intensive and repetitive practice of reaching by stroke survivors with severe upper limb disability, with the aim of improving upper limb function. The outcomes of SMART Arm training with or without outcome-triggered electrical stimulation (OT-stim) to augment movement and usual therapy will be compared to usual therapy alone. METHODS/DESIGN: A prospective, assessor-blinded parallel, three-group randomised controlled trial is being conducted. Seventy-five participants with a first-ever unilateral stroke less than 4 months previously, who present with severe arm disability (three or fewer out of a possible six points on the Motor Assessment Scale [MAS] Item 6), will be recruited from inpatient rehabilitation facilities. Participants will be randomly allocated to one of three dose-matched groups: SMART Arm training with OT-stim and usual therapy; SMART Arm training without OT-stim and usual therapy; or usual therapy alone. All participants will receive 20 hours of upper limb training over four weeks. Blinded assessors will conduct four assessments: pre intervention (0-weeks), post intervention (4-weeks), 26 weeks and 52 weeks follow-up. The primary outcome measure is MAS item 6. All analyses will be based on an intention-to-treat principle. DISCUSSION: By enabling intensive and repetitive practice of a functional upper limb task during inpatient rehabilitation, SMART Arm training with or without OT-stim in combination with usual therapy, has the potential to improve recovery of upper limb function in those with severe motor disability. The immediate and long-term effects of SMART Arm training on upper limb impairment, activity and participation will be explored, in addition to the benefit of training with or without OT-stim to augment movement when compared to usual therapy alone. TRIAL REGISTRATION: ACTRN12608000457347.