NCT06571292

Effect of the Dose of Training in Upper Limb Motor Recovery After Stroke.

Effect of the Dose of a Task Specific Training Program and Armeo Spring on Upper Limb Motor Recovery in Chronic Stroke: Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Universidad de Zaragoza · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to analyse the effect of intensive training on upper limb function in stroke patients. 20 stroke patients were randomly divided into two groups: the intensive group and the control group. The control group will be trained with robotic exoskeleton for upper limbs and task specific training, 3 sessions per week for 4 weeks, for 1 hour per day. The intensive group will do robotic exoskeleton for upper limbs and task specific training, 5 sessions a week for 4 weeks, for 2 hours a day.

Detailed description

Abtract Introduction: Intensive rehabilitation and task-specific training (TST) are essential for recovery after stroke. Devices such as Armeo Spring allow for increased repetitions while maintaining specificity. The objective was to compare the effect of a high-repetition dose versus a low-repetition dose using a combined program of Armeo Spring and TST on upper limb recovery in patients with chronic stroke. Methods: Randomized, single-blind clinical trial with 20 participants (\>6 months post-stroke). Participants were assigned to two groups: High Repetition (HR; 40 hours total, 2 hours/session, 5 days/week) and Low Repetition (LR; 12 hours total, 1 hour/session, 3 days/week) for 4 weeks. The primary outcome measure was the Fugl-Meyer Assessment-Upper Extremity (FMA-UE). Assessments were performed at baseline (T0), post-intervention (T1), and one month (T2). Results: Both groups showed significant improvements in the FMA-UE (p \< 0.01). The HR group improved by 10.80 points (SD = 5.92) and the BR group by 5.90 points (SD = 3.54) at T1 and remained stable at T2. The intergroup comparison significantly favored the HR group at T1 and T2 (p \< 0.02), with superior benefits also in dexterity, independence, and perception of performance. The effect size was greater in the HR group (d = 0.712) than in the LR group (d = 0.435) between T0 and T1, but at T2, the effect size was small in both groups. Conclusions: Armeo Spring therapy and high-repetition TST proved to be more effective in improving upper limb functionality in patients with chronic stroke at the end of the intervention and at the one-month follow-up.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Intensive training with robotic exoskeleton for upper limbs	Both groups will be trained with robotic exoskeleton for upper limbs and task specific training.
DEVICE	Task specific training	Both groups will be trained with robotic exoskeleton for upper limbs and task specific training.

Timeline

• Start date: 2024-07-05
• Primary completion: 2024-08-30
• Completion: 2024-10-04
• First posted: 2024-08-26
• Last updated: 2026-03-04

Locations

1 site across 1 country: Spain