Back to resultsThe Effect of Motor Learning on Balance, Mobility and Performance of Activities of Daily Living Among Post-Stroke Patients
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Study Group (Motor relearning program)
Control Group (Conventional physical therapy program)
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Motor learning, Balance, Mobility
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.
Sites / Locations
- Centre Fòrum, Parc de Salut MarRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Motor relearning program (MRP)
Conventional physical therapy program (CPT)
Arm Description
Outcomes
Primary Outcome Measures
Berg Balance Scale (BBS)
Timed Up and Go Test (TUG)
10-meter Walk Test (10mWT)
Barthel Index (BI)
Instrumental analysis of balance
The balance and postural control will be assessed using the computerized posturography - NedSVE/IBV® platform.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05076383
Brief Title
The Effect of Motor Learning on Balance, Mobility and Performance of Activities of Daily Living Among Post-Stroke Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Rehabilitation, Motor learning, Balance, Mobility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Motor relearning program (MRP)
Arm Type
Experimental
Arm Title
Conventional physical therapy program (CPT)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Study Group (Motor relearning program)
Intervention Description
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
Intervention Name(s)
Control Group (Conventional physical therapy program)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Title
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).
Title
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).
Title
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).
Title
Instrumental analysis of balance
Description
The balance and postural control will be assessed using the computerized posturography - NedSVE/IBV® platform.
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).
Title
Instrumental analysis of gait
Description
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.
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amer Ghrouz
Phone
+34671100773
Email
a.k.ghrouz@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amer Ghrouz, PhD Student
Organizational Affiliation
Physical Medicine and Rehabilitation, Centre Fòrum, Parc de Salut Mar, Barcelona, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Esther Duarte, MD, PhD
Organizational Affiliation
Physical Medicine and Rehabilitation, Hospitals del Mar i l'Esperança, Parc de Salut Mar, Barcelona, Spain
Official's Role
Study Director
Facility Information:
Facility Name
Centre Fòrum, Parc de Salut Mar
City
Barcelona
ZIP/Postal Code
08019
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amer Ghrouz
Phone
+34671100773
Email
a.k.ghrouz@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
35300258
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Motor Learning on Balance, Mobility and Performance of Activities of Daily Living Among Post-Stroke Patients
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