StrokeNCT06476782
Motor Relearning Program and Aerobic Exercise in Postural Stability and Lower Limb Function in Subacute Stroke Patients
A study testing Motor Relearning Program(MRP) and aerobic exercise and Motor Relearning Program(MRP) in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of the study is to determine combined effects of MRP and aerobic exercise in postural stability and lower limb function in subacute stroke patients Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Motor Relearning Program(MRP) and aerobic exercise and Motor Relearning Program(MRP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2024to 30 Jul 2024
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Both male and female patients were included.
- Stroke patients with age range 50-70 years
- Stroke patients with no serious unstable medical complications.
- Patients with ischemic stroke
- Patients who can follow directions (written, verbal, demonstration)
- Patients who were not receiving any other form of physiotherapy treatment.
- Patients with cognition level of >24 on MMSE scale
- Stroke patients with 1 to 5 months of stroke history (Sub-Acute Stroke Patients)
Who cannot join
- • Patients with any cardiac problem
- Patients with history of any other neurological disease other than stroke.
- Patients with peripheral arterial occlusive disease
- Patients with surgeries like amputations of lower limb
- MAS score > +3 were not included
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Islam Central Hospital , New life hospital
Sialkot, Punjab Province, 51040
Hira Jabeen, MsNmpt, +92 323 4116506, hira.jabeen@riphah.edu.pk
Maham Nasir, Dpt
About this study
Official title: Combined Effects of Motor Relearning Program and Aerobic Exercise in Postural Stability and Lower Limb Function in Subacute Stroke Patients
The aim of the study is to determine combined effects of MRP and aerobic exercise in postural stability and lower limb function in subacute stroke patients
Read the detailed description
A study was done in 2023 on the treatment effects of low frequency repetitive Trans cranial magnetic stimulation combined with motor relearning program on spasticity and limb motor function in stroke patients. Stroke patients were randomly assigned into a control group and a combined treatment group. The Fugl Meyer scale, the Motor Evoked Potential test, and the Modified Ashworth scale were the instruments utilized. They came to the conclusion that low frequency rTMS plus MRP was more effective than MRP alone at improving spasticity and motor function in stroke patients with hemiparesis.
A study was done in 2023 on the effect of motor relearning program with obstacle walking on dynamic gait performance and functional mobility in sub-acute stroke subjects in India.Group B underwent a 30-minute obstacle walking program in addition to Group A's motor relearning program. Group comparison of the DGI and MAS pre- and post-test results revealed statistically significant differences in both groups. In order to improve dynamic gait performance and functional mobility in sub-acute stroke patients, they found that while both interventions were effective on their own, the motor relearning program in conjunction with obstacle walking was superior to the motor relearning program used alone.
A study was done on effects of the home-based exercise program with an augmented reality system on balance in patients with stroke; a randomized controlled trial in 2022. 68 stroke patients were enrolled in this study under the supervision of a blind observer. The written and visual HEP was administered to patients in the smart rehabilitation group. They came to the conclusion that the smart-rehabilitation group had a greater change in balance than the control group.
A study was done in 2019 on the impact of proprioceptive neuromuscular facilitation and motor relearning on improving functional mobility in individuals with sub-acute stroke. The goal of the research was to determine whether proprioceptive neuromuscular facilitation and motor relearning could improve functional mobility in patients with sub-acute strokes. There were thirty subjects, aged 45-55, who were in stages 3 and 4 of Brunnstrom recovery after having a stroke. They concluded that compared to subjects treated with proprioceptive neuromuscular facilitation alone, those treated with a motor relearning program and proprioceptive neuromuscular facilitation showed improvements in functional mobility.
In another study which was done in 2018 on the topic aerobic with resistance training or aerobic training alone post stroke: A secondary analysis from a RCT. They investigated the effects of AT+RT versus AT on psychological outcomes in chronic stroke with motor impairments. They concluded AT+RT versus AT yielded similar significant improvement.
Many studies have determined the effects of motor relearning program and proprioceptive neuromuscular facilitation on functional mobility and balance but according to the researcher's knowledge there is no evidence of effects of motor relearning program on postural stability. Moreover, the effects of aerobic exercise on cardiovascular fitness and upper limb function have strong evidence but little research has been done on the effects of aerobic exercise on lower limb in stroke patients. The literature gap between studies on effects of aerobic exercise and motor relearning program is wide. The aim of this study is to bridge this gap by providing evidence-based recommendations and optimizing exercise strategies tailored to the unique needs of the sub-acute stroke patients.
- Conditions
- Stroke
- Being tested
- Motor Relearning Program(MRP) and aerobic exercise, Motor Relearning Program(MRP)
- Keywords
- Aerobic exercise, Stroke, MRP
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Relearning Program(MRP) and aerobic exerciseOther
Participants of this group received training for a total of 8 weeks in the form of 3 sessions per week each session of 40 minutes, with a total of 24 sessions.
Motor Relearning Program(MRP)Other
the week 8 session was held in which patients were involved in 60-minute activities that involved practicing functional tasks without explicitly giving any type of relationship between those learned skills and the remedial tasks.
| Study group | Role | What they receive |
|---|---|---|
| Combined MRP and aerobic exercise | Experimental | Group A received MRP treatment and aerobic exercise along with conventional therapy Receives: Other: Motor Relearning Program(MRP) and aerobic exercise |
| MRP group | Experimental | Group B received MRP treatment along with conventional therapy Receives: Other: Motor Relearning Program(MRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural assessment scale for e
The postural assessment scale for stroke is an outcome measure specifically designed to assess and monitor postural control after stroke.The PASS consists of a 4-point scale where items are scored from 0 - 3. The total score ranges from 0 - 36.The higher the score is, the more favourable the balance in stroke patients.
Measured: 8th week
Lower extremity functional scale
LEF is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. LEFS is scored on a scale of 0 to 80, with higher scores indicating better lower limb function. The interpretation of the scores can be based on the following categories: 0-20: Severe functional limitation. 21-40: Moderate functional limitation.
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Feb 2024
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476782
- Sponsor's protocol ID
- REC/RCR&AHS/23/02102
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen R, Zhang Y, Wang X, Zhao Y, Fan S, Xue Y, Zhao J, Liu Y, Wang P. Treatment effects of low-frequency repetitive transcranial magnetic stimulation combined with motor relearning procedure on spasticity and limb motor function in stroke patients. Front Neurol. 2023 Aug 11;14:1213624. doi: 10.3389/fneur.2023.1213624. eCollection 2023.
PubMed 37638202Lee JI, Park J, Koo J, Son M, Hwang JH, Lee JY, Chang WH. Effects of the home-based exercise program with an augmented reality system on balance in patients with stroke: a randomized controlled trial. Disabil Rehabil. 2023 May;45(10):1705-1712. doi: 10.1080/09638288.2022.2074154. Epub 2022 May 15.
PubMed 35574910Marzolini S, Brooks D, Oh P, Jagroop D, MacIntosh BJ, Anderson ND, Alter D, Corbett D. Aerobic With Resistance Training or Aerobic Training Alone Poststroke: A Secondary Analysis From a Randomized Clinical Trial. Neurorehabil Neural Repair. 2018 Mar;32(3):209-222. doi: 10.1177/1545968318765692. Epub 2018 Mar 30.
PubMed 29600726
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Motor Relearning Program and Aerobic Exercise in Postural Stability and Lower Limb Function in Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT06476782
- Acronym / sponsor ID
- REC/RCR&AHS/23/02102
- Conditions
- Stroke
- Keywords
- Aerobic exercise, Stroke, MRP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 26 Jun 2024 (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 aim of the study is to determine combined effects of MRP and aerobic exercise in postural stability and lower limb function in subacute stroke patients
Detailed description
A study was done in 2023 on the treatment effects of low frequency repetitive Trans cranial magnetic stimulation combined with motor relearning program on spasticity and limb motor function in stroke patients. Stroke patients were randomly assigned into a control group and a combined treatment group. The Fugl Meyer scale, the Motor Evoked Potential test, and the Modified Ashworth scale were the instruments utilized. They came to the conclusion that low frequency rTMS plus MRP was more effective than MRP alone at improving spasticity and motor function in stroke patients with hemiparesis.
A study was done in 2023 on the effect of motor relearning program with obstacle walking on dynamic gait performance and functional mobility in sub-acute stroke subjects in India.Group B underwent a 30-minute obstacle walking program in addition to Group A's motor relearning program. Group comparison of the DGI and MAS pre- and post-test results revealed statistically significant differences in both groups. In order to improve dynamic gait performance and functional mobility in sub-acute stroke patients, they found that while both interventions were effective on their own, the motor relearning program in conjunction with obstacle walking was superior to the motor relearning program used alone.
A study was done on effects of the home-based exercise program with an augmented reality system on balance in patients with stroke; a randomized controlled trial in 2022. 68 stroke patients were enrolled in this study under the supervision of a blind observer. The written and visual HEP was administered to patients in the smart rehabilitation group. They came to the conclusion that the smart-rehabilitation group had a greater change in balance than the control group.
A study was done in 2019 on the impact of proprioceptive neuromuscular facilitation and motor relearning on improving functional mobility in individuals with sub-acute stroke. The goal of the research was to determine whether proprioceptive neuromuscular facilitation and motor relearning could improve functional mobility in patients with sub-acute strokes. There were thirty subjects, aged 45-55, who were in stages 3 and 4 of Brunnstrom recovery after having a stroke. They concluded that compared to subjects treated with proprioceptive neuromuscular facilitation alone, those treated with a motor relearning program and proprioceptive neuromuscular facilitation showed improvements in functional mobility.
In another study which was done in 2018 on the topic aerobic with resistance training or aerobic training alone post stroke: A secondary analysis from a RCT. They investigated the effects of AT+RT versus AT on psychological outcomes in chronic stroke with motor impairments. They concluded AT+RT versus AT yielded similar significant improvement.
Many studies have determined the effects of motor relearning program and proprioceptive neuromuscular facilitation on functional mobility and balance but according to the researcher's knowledge there is no evidence of effects of motor relearning program on postural stability. Moreover, the effects of aerobic exercise on cardiovascular fitness and upper limb function have strong evidence but little research has been done on the effects of aerobic exercise on lower limb in stroke patients. The literature gap between studies on effects of aerobic exercise and motor relearning program is wide. The aim of this study is to bridge this gap by providing evidence-based recommendations and optimizing exercise strategies tailored to the unique needs of the sub-acute stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined MRP and aerobic exercise | Experimental | Other: Motor Relearning Program(MRP) and aerobic exerciseGroup A received MRP treatment and aerobic exercise along with conventional therapy |
| MRP group | Experimental | Other: Motor Relearning Program(MRP)Group B received MRP treatment along with conventional therapy |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Both male and female patients were included.
Key exclusion criteria (5 listed)
- • Patients with any cardiac problem
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 |
|---|---|---|
| Motor Relearning Program(MRP) and aerobic exerciseParticipants of this group received training for a total of 8 weeks in the form of 3 sessions per week each session of 40 minutes, with a total of 24 sessions. | Other | Combined MRP and aerobic exercise |
| Motor Relearning Program(MRP)the week 8 session was held in which patients were involved in 60-minute activities that involved practicing functional tasks without explicitly giving any type of relationship between those learned skills and the remedial tasks. | Other | MRP group |
Primary outcome
Postural assessment scale for e
Time frame: 8th week
The postural assessment scale for stroke is an outcome measure specifically designed to assess and monitor postural control after stroke.The PASS consists of a 4-point scale where items are scored from 0 - 3. The total score ranges from 0 - 36.The higher the score is, the more favourable the balance in stroke patients.
Lower extremity functional scale
Time frame: 8th week
LEF is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. LEFS is scored on a scale of 0 to 80, with higher scores indicating better lower limb function. The interpretation of the scores can be based on the following categories: 0-20: Severe functional limitation. 21-40: Moderate functional limitation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Background: PubMed 37638202Chen R, Zhang Y, Wang X, Zhao Y, Fan S, Xue Y, Zhao J, Liu Y, Wang P. Treatment effects of low-frequency repetitive transcranial magnetic stimulation combined with motor relearning procedure on spasticity and limb motor function in stroke patients. Front Neurol. 2023 Aug 11;14:1213624. doi: 10.3389/fneur.2023.1213624. eCollection 2023.
- Background: PubMed 35574910Lee JI, Park J, Koo J, Son M, Hwang JH, Lee JY, Chang WH. Effects of the home-based exercise program with an augmented reality system on balance in patients with stroke: a randomized controlled trial. Disabil Rehabil. 2023 May;45(10):1705-1712. doi: 10.1080/09638288.2022.2074154. Epub 2022 May 15.
- Background: PubMed 29600726Marzolini S, Brooks D, Oh P, Jagroop D, MacIntosh BJ, Anderson ND, Alter D, Corbett D. Aerobic With Resistance Training or Aerobic Training Alone Poststroke: A Secondary Analysis From a Randomized Clinical Trial. Neurorehabil Neural Repair. 2018 Mar;32(3):209-222. doi: 10.1177/1545968318765692. Epub 2018 Mar 30.
- Individual participant dataSharing planned: No
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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.
Aruba Saeed, Phd principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Relearning Program(MRP) and aerobic exercise and Motor Relearning Program(MRP) in people with Stroke, run by Riphah International University at 1 site in Pakistan.
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 8 inclusion and 5 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 26 Jun 2024. 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 Pakistan. 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 Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural assessment scale for e (time frame: 8th week). The study lists 2 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 NCT06476782, which also lists 3 linked publications.
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 26 Jun 2024.