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

May 15, 2022 updated by: Amer Ghrouz, Parc de Salut Mar

The Effect of Motor Re-Learning Program on Balance, Mobility and Performance of Activities of Daily Living Among Post-Stroke Patients: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08019
        • Recruiting
        • Centre Fòrum, Parc de Salut Mar
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motor relearning program (MRP)
Other: 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.
Active Comparator: Conventional physical therapy program (CPT)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale (BBS)
Time Frame: 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).
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)
Time Frame: 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).
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)
Time Frame: 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).
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)
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Investigators

  • Principal Investigator: Amer Ghrouz, PhD Student, Physical Medicine and Rehabilitation, Centre Fòrum, Parc de Salut Mar, Barcelona, Spain
  • Study Director: Esther Duarte, MD, PhD, Physical Medicine and Rehabilitation, Hospitals del Mar i l'Esperança, Parc de Salut Mar, Barcelona, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

September 30, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 15, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/9986/I

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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