StrokeNCT05076383
The Effect of Motor Learning on Balance, Mobility and Performance of Activities of Daily Living Among Post-Stroke Patients
A study testing Study Group (Motor relearning program) in people with Stroke, run by Parc de Salut Mar at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Study Group (Motor relearning program)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2021to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Centre Fòrum, Parc de Salut Mar
Barcelona, 08019
Amer Ghrouz, +34671100773, a.k.ghrouz@hotmail.com
About this study
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
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.
- Conditions
- Stroke
- Being tested
- Study Group (Motor relearning program), Control Group (Conventional physical therapy program)
- Keywords
- Rehabilitation, Motor learning, Balance, Mobility
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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 group | Role | What they receive |
|---|---|---|
| Motor relearning program (MRP) | Experimental | Not described Receives: Other: Study Group (Motor relearning program) |
| Conventional physical therapy program (CPT) | Active comparator | Not described Receives: Other: Control Group (Conventional physical therapy program) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start1 Oct 2021
- Primary completionOct 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amer Ghrouz, Parc de Salut Mar
- Investigators
- Amer Ghrouz, PhD Student, Principal investigator, Physical Medicine and Rehabilitation, Centre Fòrum, Parc de Salut Mar, Barcelona, SpainEsther Duarte, MD, PhD, Study director, Physical Medicine and Rehabilitation, Hospitals del Mar i l'Esperança, Parc de Salut Mar, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076383
- Sponsor's protocol ID
- 2021/9986/I
- Status last verified
- May 2022
- First submitted
- 22 Sep 2021
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35300258
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05076383
- Acronym / sponsor ID
- 2021/9986/I
- Conditions
- Stroke
- Keywords
- Rehabilitation, Motor learning, Balance, Mobility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor relearning program (MRP) | Experimental | Other: Study Group (Motor relearning program) |
| Conventional physical therapy program (CPT) | Active comparator | Other: Control Group (Conventional physical therapy program) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Motor relearning program (MRP) |
| 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. | Other | Conventional physical therapy program (CPT) |
Primary outcome
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).
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).
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 35300258Ghrouz 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amer Ghrouz, PhD Student principal investigator
Physical Medicine and Rehabilitation, Centre Fòrum, Parc de Salut Mar, Barcelona, Spain
Esther Duarte, MD, PhD study director
Physical Medicine and Rehabilitation, Hospitals del Mar i l'Esperança, Parc de Salut Mar, Barcelona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Group (Motor relearning program) in people with Stroke, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amer Ghrouz (+34671100773, a.k.ghrouz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05076383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.