The Effect of Motor Learning on Balance, Mobility and Performance of Activities of Daily Living Among Post-Stroke Patients

NCT ID: NCT05076383

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-01-31

Brief Summary

The primary objective of this study is to assess - through a randomized controlled trial - the effectiveness and long-term improvement of motor relearning program on balance, mobility and performance of activities of daily living among post-stroke patients. In this two-armed randomized controlled clinical trial, a total of 66 sub-acute stroke patients who meet the trial criteria will be recruited. The patients will randomly receive task-specific training based on a motor relearning program (MRP) or a conventional physical therapy program (CPT). Twenty-four rehabilitation sessions will be conducted for eight weeks. Both interventions will be followed by analysis of patients' balance, gait and performance of activates of daily living at two time period; post-intervention and follow-up after 3-months, using clinical outcome measures and instrumental analysis of balance and gait.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Motor relearning program (MRP)

Group Type: EXPERIMENTAL

Study Group (Motor relearning program)

Intervention Type: OTHER

Task-specific training based on motor relearning program will be performed for 8 weeks (3 sessions per week; 1 hr. per session; total 24 sessions). Each training session will consist of five training tasks: (1) bed mobility and sitting up over the side of the bed; (2) balanced sitting; (3) standing up and sitting down; (4) balanced standing; and (5) practice of walking.

Conventional physical therapy program (CPT)

Group Type: ACTIVE_COMPARATOR

Control Group (Conventional physical therapy program)

Intervention Type: OTHER

The conventional physical therapy program (CPT) exercises will be performed following a standard stroke rehabilitation program for 8 weeks (3 sessions per week; 1 hr. per session; total 24 sessions). Each CPT rehabilitation session will include the following exercises: (1) passive and active-assisted range of motion; (2) stretching; (3) strengthening exercises; (4) balance exercises; and (5) walking.

Interventions

Study Group (Motor relearning program)

Task-specific training based on motor relearning program will be performed for 8 weeks (3 sessions per week; 1 hr. per session; total 24 sessions). Each training session will consist of five training tasks: (1) bed mobility and sitting up over the side of the bed; (2) balanced sitting; (3) standing up and sitting down; (4) balanced standing; and (5) practice of walking.

Intervention Type: OTHER

Control Group (Conventional physical therapy program)

The conventional physical therapy program (CPT) exercises will be performed following a standard stroke rehabilitation program for 8 weeks (3 sessions per week; 1 hr. per session; total 24 sessions). Each CPT rehabilitation session will include the following exercises: (1) passive and active-assisted range of motion; (2) stretching; (3) strengthening exercises; (4) balance exercises; and (5) walking.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• First-ever subacute (1-6 months) stroke patients;
• Able to give informed consent;
• Patients with hemiparesis: muscle power of 2-4 on Medical Research Council-MRC Muscle Scale in the affected upper and lower limbs;
• Able to stand independently for at least one minute;
• Can ambulate 25 feet/10 meter (with or without assistive device).

Exclusion Criteria

• Post-stroke patients with major cognitive deficits (Montreal Cognitive Assessment- MoCA score ≥ 20) and/or communication impairments that don't allow patients to follow directions (i.e., deafness, aphasia, etc.);
• Patients who are receiving other related therapy through the study, which may affect efficacy of this study;
• Any medical contraindications to start rehabilitation;
• History of disability related to neurological deficits other than stroke.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

Amer Ghrouz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amer Ghrouz, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Physical Medicine and Rehabilitation, Centre Fòrum, Parc de Salut Mar, Barcelona, Spain

Esther Duarte, MD, PhD

Role: STUDY_DIRECTOR

Physical Medicine and Rehabilitation, Hospitals del Mar i l'Esperança, Parc de Salut Mar, Barcelona, Spain

Locations

Centre Fòrum, Parc de Salut Mar

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Amer Ghrouz

Role: CONTACT

a.k.ghrouz@hotmail.com

+34671100773

Facility Contacts

Amer Ghrouz

Role: primary

a.k.ghrouz@hotmail.com

+34671100773

References

Ghrouz A, Marco E, Munoz-Redondo E, Boza R, Ramirez-Fuentes C, Duarte E. The effect of motor relearning on balance, mobility and performance of activities of daily living among post-stroke patients: Study protocol for a randomised controlled trial. Eur Stroke J. 2022 Mar;7(1):76-84. doi: 10.1177/23969873211061027. Epub 2022 Feb 11.

Reference Type: DERIVED

PMID: 35300258 (View on PubMed)

Other Identifiers

2021/9986/I

Identifier Type: -

Identifier Source: org_study_id