Clinical trial NCT05076383: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Rehabilitation
Motor learning
Balance
Mobility
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: 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).
measure: Timed Up and Go Test (TUG)
timeFrame: 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).
measure: 10-meter Walk Test (10mWT)
timeFrame: 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).
measure: Barthel Index (BI)
timeFrame: 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).
measure: Instrumental analysis of balance
timeFrame: 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).
measure: Instrumental analysis of gait
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centre Fòrum, Parc de Salut Mar
Study officials:
affiliation: Physical Medicine and Rehabilitation, Centre Fòrum, Parc de Salut Mar, Barcelona, Spain
name: Amer Ghrouz, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Physical Medicine and Rehabilitation, Hospitals del Mar i l'Esperança, Parc de Salut Mar, Barcelona, Spain
name: Esther Duarte, MD, PhD
role: STUDY_DIRECTOR
References:
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.