Effects of Neuropilates on Rehabilitation Programs for Chronic Stroke

NCT ID: NCT06127485

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2023-11-15

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.

Conditions

Stroke; Occupational Therapy; Physiotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

The treatment received is a combination of physiotherapy and conventional occupational therapy sessions two days a week, with a duration of 60 minutes divided into 30 minutes of physiotherapy and 30 minutes of occupational therapy.

Group Type: ACTIVE_COMPARATOR

Occupational Therapy and Physiotherapy conventional

Intervention Type: PROCEDURE

Conventional physical therapy in both groups will include stretching techniques and muscle activation of the lower limb and gait reeducation. Conventional occupational therapy will include stretching techniques and muscle activation in the upper limb as well as training in activities of daily living and functional activities of the upper limb.

Experimental Group

The experimental group received 60 minutes of conventional rehabilitation combined with the Pilates Method, divided into 20 minutes of physiotherapy, 20 minutes of occupational therapy and 20 minutes of Pilates Method.

Group Type: EXPERIMENTAL

Neuropilates+occupational therapy and physiotherapy conventional

Intervention Type: PROCEDURE

Participants assigned to the experimental group received 60 minutes of conventional rehabilitation combined with the Pilates Method, divided into 20 minutes of physical therapy, 20 minutes of occupational therapy and 20 minutes of Pilates Method. Pilates routines will be performed on a mat through the practice of Pilates activation exercises. Each participant will be given the necessary adaptations of each exercise according to their difficulties/disabilities.

Interventions

Neuropilates+occupational therapy and physiotherapy conventional

Participants assigned to the experimental group received 60 minutes of conventional rehabilitation combined with the Pilates Method, divided into 20 minutes of physical therapy, 20 minutes of occupational therapy and 20 minutes of Pilates Method. Pilates routines will be performed on a mat through the practice of Pilates activation exercises. Each participant will be given the necessary adaptations of each exercise according to their difficulties/disabilities.

Intervention Type: PROCEDURE

Occupational Therapy and Physiotherapy conventional

Conventional physical therapy in both groups will include stretching techniques and muscle activation of the lower limb and gait reeducation. Conventional occupational therapy will include stretching techniques and muscle activation in the upper limb as well as training in activities of daily living and functional activities of the upper limb.

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: lead

Responsible Party

Sara Garcia Bravo

PhD Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara García-Bravo

Role: STUDY_DIRECTOR

Universidad Rey Juan Carlos

Locations

Physiocare Madrid

Madrid, , Spain

Countries

Spain

Other Identifiers

3006202326123

Identifier Type: -

Identifier Source: org_study_id