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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05076383
• Other study ID #: 2021/9986/I
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: January 2023

Study information

• Verified date: May 2022
• Source: Parc de Salut Mar
• Contact: Amer Ghrouz
• Phone: +34671100773
• Email: a.k.ghrouz[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: January 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Study Group (Motor relearning program)
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.
• Control Group (Conventional physical therapy program)
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.

Locations

Country	Name	City	State
Spain	Centre Fòrum, Parc de Salut Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).