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

NCT05076383 | Unknown

• 1 other identifier: 2021/9986/I
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

Rehabilitation; Motor learning; Balance; Mobility

Outcome Measures

Primary Outcomes (6)

• Berg Balance Scale (BBS)

  The BBS will be used to assess the changes from the baseline balance at 8 weeks (post-intervention) as well as at 3-months after intervention (3-months follow-up).

• Timed Up and Go Test (TUG)

  The TUG will be used to evaluate the changes from baseline functional mobility at 8 weeks (post-intervention) as well as at 3-months after intervention (3-months follow-up).

• 10-meter Walk Test (10mWT)

  The 10mWT will be used to assess the changes from the baseline walking speed (meters per second) at 8 weeks (post-intervention) as well as at 3-months after intervention (3-months follow-up).

• Barthel Index (BI)

  The BI will be used to measure the changes from baseline functional independency at 8 weeks (post-intervention) as well as at 3-months after intervention (3-months follow-up).

• Instrumental analysis of balance

  The balance and postural control will be assessed using the computerized posturography - NedSVE/IBV® platform.

  NedSVE/IBV® system will be used to assess the changes from baseline balance and postural control at 8 weeks (post-intervention) as well as at 3-months after intervention (3-months follow-up).

• Instrumental analysis of gait

  The gait will be assessed using the NedAMH/IBV® system, a software application for the biomechanical gait assessment, based on the use of a Dinascan/IBV P600 dynamometric platform.

  NedAMH/IBV® system will be used to assess the changes from baseline gait parameters at 8 weeks (post-intervention) as well as at 3-months after intervention (3-months follow-up).

Study Arms (2)

Motor relearning program (MRP)

EXPERIMENTAL

Other: Study Group (Motor relearning program)

Conventional physical therapy program (CPT)

ACTIVE COMPARATOR

Other: Control Group (Conventional physical therapy program)

Interventions

Study Group (Motor relearning program) 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.

Motor relearning program (MRP)

Control Group (Conventional physical therapy program) 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.

Conventional physical therapy program (CPT)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Centre Fòrum, Parc de Salut Mar

Barcelona, 08019, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 35300258 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Amer Ghrouz, PhD Student

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

  PRINCIPAL INVESTIGATOR

• Esther Duarte, MD, PhD

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

  STUDY DIRECTOR

Central Study Contacts

Amer Ghrouz

CONTACT

+34671100773; a.k.ghrouz@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 13, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: January 1, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

ES (1)