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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Intensive training with robotic exoskeleton for upper limbs; Device: Task specific training

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • University of Zaragoza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• People diagnosed with stroke (ischaemic or haemorrhagic).
• Patients in a subacute or chronic state.
• Patients must be over 18 years of age and under 80 years of age.
• Patients with impaired functionality of the upper limb.

Exclusion Criteria:

• Persons diagnosed with other pathologies, other than those indicated in the inclusion criteria.
• Montreal Cognitive Assessment (MoCA), the minimum score to be achieved will be 22 points.
• Severe difficulties in understanding language (aphasia).
• Behavioural or behavioural disturbance.
• Treatment with botulinum toxin 3 months prior to the intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: Intensive group; The intensive group will be trained with robotic exoskeleton for upper limbs and task specific training, 5 sessions per week for 4 weeks, for 2 hours per day.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl Meyer Assesment (FMA)	Primary Outcome Measure. It is a scale where the area of assessment includes ADLs, functional mobility and pain. ICF Domain, Body Function.Minimal Detectable Change (MDC) FMA = 5.2 points for the Upper Extremity portion of the assessment	Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Box and Blocks Test (BBT)	Secondary Outcome Measures.Assesses unilateral gross manipulative skills.ICF Domain Activity.Minimal Detectable Change (MDC)MDC: 5.5 blocks per minute	Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Dynamometer	Secondary Outcome Measures.A quantitative and objective measure of isometric muscular strength of the hand and forearm. ICF Domain Body Structure Body Function. Minimally Clinically Important Difference (MCID) 5.0 and 6.2 (kg) for the affected dominant and non-dominant sides.	Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Motor Activity Log (MAL)	Secondary Outcome Measures. The MAL is a semi-structured interview to assess arm function. ICF Domain Activity Participation. Minimal Detectable Change (MDC)MDC= 0.56- 1.06	Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Stroke Impact Scale (SIS). To assess physical function following stroke. ICF Domain Activity. Minimal Detectable Change (MDC)MDC >= 8	Secondary Outcome Measures	Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Funcitonal Independence Measure (FIM)	Secondary Outcome Measures. Provides a uniform system of measurement for disability based on the International Classification of Impairment, Disabilities and Handicaps; measures the level of a patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living.ICF Domain Activity. Minimally Clinically Important Difference (MCID) FIM Total Score = 22 points	Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Canadian Occupational Performance Measure (COPM)	Secondary Outcome Measures. The COPM assesses an individual's perceived occupational performance in the areas of self-care, productivity, and leisure.ICF Domain Participation.Minimal Detectable Change (MDC) MDC for performance=1.7 points MDC for satisfaction=2.7 points	Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assesment (MOCA)	Exclusion criterio. Rapid screen of cognitive abilities designed to detect mild cognitive dysfunction.	Prior to the baseline assessment

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2024
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): October 4, 2024

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; upper limb; occupational therapy; intensive training
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Equipment and Supplies; Exoskeleton Device
• Other Study ID Numbers: University Zaragoza

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No