Effectiveness of Intensive Training in Upper Limb Rehabilitation After Stroke.

University of Zaragoza

Status: Completed

Conditions: Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06571292

University Zaragoza

Details and patient eligibility

About

The aim of the study is to analyse the effect of intensive training on upper limb function in stroke patients.

16 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.

Full description

Abtract

Aim: The aim of the study is to analyze the effect of intensive training on upper limb function in stroke patients.

Methods: 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. The primary outcome measure include is the Fugl Meyer Assessment (FMA).Secondary measures include the Box and Blocks Test (BBT), dynamometer, Motor Activity Log (MAL), Stroke Impact Scale (SIS), Functional Independence Measure (FIM) and Canadian Occupational Performance Measure (COPM).

Assessments occur at baseline, after 4 weeks of intervention, and at 1 month after intervention commencement. Analysis will be intention to treat using a generalised linear mixed model to report estimated mean differences in scores between the two groups at each timepoint with 95% confidence Interval and value p.

Hypothesis: If an intensive training programme is effective in improving upper limb motor function, its implementation for clinical practice could be beneficial for improving upper limb motor function and quality of life in people who have suffered a stroke.

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.
• Mini-Mental State Examination (MMSE), 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Device: Intensive training with robotic exoskeleton for upper limbs

Device: Task specific training

Intensive group

Experimental group

Description:

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.

Treatment:

Device: Intensive training with robotic exoskeleton for upper limbs

Device: Task specific training