Skip to main content
OpenTrials
Completed

NCT Number: NCT06571292

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Zaragoza

Zaragoza, 50009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intensive training with robotic exoskeleton for upper limbs

Device

Both groups will be trained with robotic exoskeleton for upper limbs and task specific training.

Task specific training

Device

Both groups will be trained with robotic exoskeleton for upper limbs and task specific training.

Primary outcomes

  1. Fugl Meyer Assesment (FMA)

    Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement

    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

Secondary outcomes

  1. Box and Blocks Test (BBT)

    Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.

    Secondary Outcome Measures.Assesses unilateral gross manipulative skills.ICF Domain Activity.Minimal Detectable Change (MDC)MDC: 5.5 blocks per minute

  2. Dynamometer

    Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.

    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.

  3. Motor Activity Log (MAL)

    Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.

    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

  4. Stroke Impact Scale (SIS). To assess physical function following stroke. ICF Domain Activity. Minimal Detectable Change (MDC)MDC >= 8

    Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.

    Secondary Outcome Measures

  5. Funcitonal Independence Measure (FIM)

    Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.

    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

  6. Canadian Occupational Performance Measure (COPM)

    Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.

    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

Other outcomes

  1. Montreal Cognitive Assesment (MOCA)

    Time frame: Prior to the baseline assessment

    Exclusion criterio. Rapid screen of cognitive abilities designed to detect mild cognitive dysfunction.

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2024
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.