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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motor relearning program (MRP) | Experimental |
| |
| Conventional physical therapy program (CPT) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amer Ghrouz | Contact | +34671100773 | a.k.ghrouz@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Fòrum, Parc de Salut Mar | Recruiting | Barcelona | 08019 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35300258 | Derived | 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. |
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| 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. |
|
| Study Director |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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