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

Not Applicable

• Conditions: Stroke
• Interventions: Other: Study Group (Motor relearning program); Other: Control Group (Conventional physical therapy program)

• Registration Number: NCT05076383
• Lead Sponsor: Parc de Salut Mar

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-09-30
• Study Start: 2021-10-01
• Study First Posted: 2021-10-13
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-15
• Last Update Posted: 2022-05-17
• Primary Completion: 2022-10
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motor relearning program (MRP)	Study Group (Motor relearning program)	-
Conventional physical therapy program (CPT)	Control Group (Conventional physical therapy program)	-

Primary Outcome Measures

Name	Time	Method
Instrumental analysis of gait	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)	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).
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).
Instrumental analysis of balance	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.

Trial Locations

Locations (1)

Centre Fòrum, Parc de Salut Mar; 🇪🇸 Barcelona, Spain