StrokeNCT06571292
Effect of the Dose of Training in Upper Limb Motor Recovery After Stroke.
A study testing Intensive training with robotic exoskeleton for upper limbs and Task specific training in people with Stroke, run by Universidad de Zaragoza at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Intensive training with robotic exoskeleton for upper limbs and Task specific training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jul 2024to 4 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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
- Being tested
- Intensive training with robotic exoskeleton for upper limbs, Task specific training
- Keywords
- Stroke, intensive training, upper limb, occupational therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive training with robotic exoskeleton for upper limbsDevice
Both groups will be trained with robotic exoskeleton for upper limbs and task specific training.
Task specific trainingDevice
Both groups will be trained with robotic exoskeleton for upper limbs and task specific training.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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. Receives: Device: Intensive training with robotic exoskeleton for upper limbs; Device: Task specific training |
| Intensive group | Experimental | 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. Receives: Device: Intensive training with robotic exoskeleton for upper limbs; Device: Task specific training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement
Secondary outcomes (6)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start5 Jul 2024
- Primary completion30 Aug 2024
- Study completion4 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrique Villa Berges, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571292
- Sponsor's protocol ID
- University Zaragoza
- Status last verified
- Mar 2026
- First submitted
- 11 Jul 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06571292
- Acronym / sponsor ID
- University Zaragoza
- Conditions
- Stroke
- Keywords
- Stroke, intensive training, upper limb, occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: Intensive training with robotic exoskeleton for upper limbs, Device: Task specific trainingThe 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. |
| Intensive group | Experimental | Device: Intensive training with robotic exoskeleton for upper limbs, Device: Task specific trainingThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive training with robotic exoskeleton for upper limbsBoth groups will be trained with robotic exoskeleton for upper limbs and task specific training. | Device | Control group, Intensive group |
| Task specific trainingBoth groups will be trained with robotic exoskeleton for upper limbs and task specific training. | Device | Control group, Intensive group |
Primary outcome
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
6 secondary outcomes
Box and Blocks Test (BBT)
Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Dynamometer
Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Motor Activity Log (MAL)
Time frame: 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
Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Funcitonal Independence Measure (FIM)
Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Canadian Occupational Performance Measure (COPM)
Time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive training with robotic exoskeleton for upper limbs and Task specific training in people with Stroke, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl Meyer Assesment (FMA) (time frame: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.