Clinical trial NCT06127485: Effects of Neuropilates on Rehabilitation Programs for Chronic Stroke
Official title: Effects of Neuropilates on Rehabilitation Programs for Chronic Stroke: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Occupational Therapy
Physiotherapy
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Cerebrovascular damage (stroke) can generate motor or cognitive sequelae, making rehabilitation (such as the Pilates method) necessary to improve autonomy and quality of life. However, there are no studies on the efficacy of the method in the recovery of the upper limb and the improvement of autonomy after stroke.

Methods: Randomized double-blind clinical trial with patients with stroke in semi-acute period, randomized into experimental group (EG) (conventional rehabilitation and Pilates) or control group (CG) (conventional rehabilitation).

After randomization and initial evaluation, the intervention will begin (2 sessions per week, 3 months). After completion, there will be post-intervention assessment, and another one at 1 month.

Intervention: The CG will receive 30 minutes of physical therapy and 30 minutes of occupational therapy. The SG will receive 20 minutes of physiotherapy, 20 minutes of occupational therapy and 20 minutes of Pilates.

Assessment instruments: Mean Functional Independence; Functional Range Test; Timed 'Up and Go'; Nine Hole Peg Test; Box and Block Test; Arm, Shoulder and Hand Disabilities Questionnaire; Client Satisfaction Questionnaire.


Eligibility criteria: Inclusion Criteria:

1. present a diagnosis of ischemic or hemorrhagic stroke with a minimum evolution of 3 months;
2. be over 18 years of age;
3. regularly attend rehabilitation treatment at the Physiocare Madrid center;
4. present moderate functional problems (score greater than 65 on the Barthel Index);
5. not present moderate cognitive impairment (Mini Mental State Examination less than 18 points);
6. not present nasogastric tubes;
7. accept to participate voluntarily in the study and sign the informed consent form;
8. be able to participate in the study and sign the informed consent form.

Exclusion Criteria:

1. time of evolution of less than 3 months;
2. other conditions of the central nervous system (tumors, anoxia, cranioencephalic trauma, etc.);
3. cardiorespiratory or neurodegenerative disorders, severe brain damage or a score of 6 or higher on the Reisberg Deterioration Scale (GDS);
4. a severely impaired level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS);
5. receiving other complementary rehabilitative therapy;
6. a severe deterioration in the level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS);
7. a severe deterioration in the level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS);
8. a severe deterioration in the level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS).

Primary outcomes:
measure: Functional Independance Measure (FIM)
timeFrame: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
measure: Functional Reach Test
timeFrame: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
measure: Timed 'Up and Go' (TUG)
timeFrame: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
measure: Nine Hole Peg Test
timeFrame: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
measure: Box and Block Test
timeFrame: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
measure: Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
timeFrame: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
Secondary outcomes:
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: post-intervention (immediately after the intervention)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Physiocare Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Sara García-Bravo
role: STUDY_DIRECTOR
References: