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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Parc de Salut Mar
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Instrumental analysis of gait
- Last Updated
- 3 years ago
Overview
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.
Investigators
Amer Ghrouz
Principal Investigator
Parc de Salut Mar
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.
Outcomes
Primary Outcomes
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.
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).
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).
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).
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).
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.