Stroke
Conditions
Keywords
Stroke, intensive training, upper limb, occupational therapy
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.
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.
Interventions
DEVICEIntensive training with robotic exoskeleton for upper limbs
Both groups will be trained with robotic exoskeleton for upper limbs and task specific training.
DEVICETask specific training
Both groups will be trained with robotic exoskeleton for upper limbs and task specific training.
Sponsors
Universidad de Zaragoza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl Meyer Assesment (FMA) | 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
| Measure | Time frame | Description |
|---|---|---|
| Box and Blocks Test (BBT) | 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 |
| Dynamometer | 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. |
| Motor Activity Log (MAL) | 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 |
| 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. | Secondary Outcome Measures |
| Funcitonal Independence Measure (FIM) | 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 |
| Canadian Occupational Performance Measure (COPM) | 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 |
Countries
Spain
Outcome results
None listed