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

NCT06571292 | Completed DMC

• 1 other identifier: University Zaragoza
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Stroke; intensive training; upper limb; occupational therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Box and Blocks Test (BBT)

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

• Dynamometer

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

• Motor Activity Log (MAL)

  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

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

• Funcitonal Independence Measure (FIM)

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

Other Outcomes (1)

• Montreal Cognitive Assesment (MOCA)

  Prior to the baseline assessment

Study Arms (2)

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.

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.

Device: Intensive training with robotic exoskeleton for upper limbs; Device: Task specific training

Interventions

Task specific training DEVICE

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

Control group; Intensive group

Intensive training with robotic exoskeleton for upper limbs DEVICE

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

Control group; Intensive group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

University of Zaragoza

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Stroke

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The principal investigator will not carry out any intervention or outcome evaluation. Both the principal investigator and the investigators of the interventions will be blinded to the data of the measurements that have been taken, and must leave the room during the assessment period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Principal investigator

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: August 26, 2024
• Study Start: July 5, 2024
• Primary Completion: August 30, 2024
• Study Completion: October 4, 2024
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)