StrokeNCT06292403
Effects of Strength Training of Non-paretic Upper and Lower Limb With or Without Mirror Therapy
A study testing Strength Training and Mirror therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to find the effects of strength training with or without mirror therapy of non-paralytic upper limb for functional activities and in lower limb for gait pattern, balance and stability, and ADLs of paralytic side in patients with acute and sub-acute stroke. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Strength Training and Mirror therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Mar 2024to 1 Jan 2025
- 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 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Girls aged 17-24 years with regular --Menstrual cycle
- Unmarried girls
Who cannot join
- Athletes
- Married women
- Girls who were regularly exercising
- Having any pelvic pathology
- Abnormal menstrual cycle.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Fatima Hospital
Rawalpindi, Punjab Province
Sara Aabroo, NMPT, 03155185508, sara.aabroo@riphah.edu.pk
Farwa Akhtar, NMPT
About this study
Official title: Effect of Strength Training of Non-paretic Upper and Lower Limb With or Without Mirror Therapy on Motor Function Recovery of the Pareytic Side in Stroke Patients.
The aim of this study is to find the effects of strength training with or without mirror therapy of non-paralytic upper limb for functional activities and in lower limb for gait pattern, balance and stability, and ADLs of paralytic side in patients with acute and sub-acute stroke. A randomized controlled trial that will include total 44 participants .The control group will undergo usual rehabilitation training along with strength training. The trial group will undergo strength training and mirror therapy of NHS on the basis of usual rehabilitation training. For the control group, training time will be 30 minutes, once a day, 3 days a week for 8 weeks. IN trial group, training time will be 30 minutes therapy, once a day, 3 days a week for 8 weeks. were allowed to rest for 3-5 min during each training. Data collected will be analyzed through SPSS 25.
Read the detailed description
Stroke is defined as rapidly developing clinical signs of focal or global cerebral function disturbance that lasts more than 24 hours or leads to death, with no other apparent cause than that of vascular origin. Hemiplegia shows one side of the body paralysis involving one upper and one lower extremity. The term hemiplegia is often used generically to refer to the wide variety of motor problems that result from stroke.There are several stroke rehabilitation strategies for UL motor impairment including strength training and mirror therapy.
The idea is to re-educate the brain through a simple task, in which the individual performs a series of movements with the healthy arm, which is reflected in the mirror as if it was the injured arm. In this way, the reflex in the mirror of the healthy arm tricks the brain in believing that the injured arm is functioning as it should before the stroke. Isokinetic strengthening may provide motor and functional improvement in paretic upper extremity among patients with post-stroke hemiplegia. This strategy makes use of the brain's adaptability to enhance motor function after a stroke .
Monika Ehrensberger et al (2019) in a study concluded potential effectiveness of mirror-aided cross-education was undertaken and results portray that, in the case of training isometrically, cross-education was not augmented by mirror therapy. (The effectiveness of strength training of the NHS is evidenced in terms of promoting recovery in patients with stroke experiencing balance, mobility, and muscle strength of the paretic side .
Chenlan Shao et al (2022) conducted his study on the effect of strength training of the non-hemiplegic side (NHS) on balance function, mobility, and muscle strength of patients with stroke. He concluded that Strength training of the NHS can promote recovery of balance, mobility, and muscle strength of the paretic side of patients with stroke.
Harris et al demonstrated that leg weakness develops on the non hemiplegic side (NHS) in the first week after acute stroke. This decline in NHS muscle strength must not be ignored in patients with stroke, because it is highly associated with functional performance, and it can be used as an independent predictor of short-term functional gain and outcomes after stroke.
The previous study investigated the feasibility and potential effectiveness of mirror-aided cross-education compared with cross-education alone in post stroke upper limb recovery only. In addition, previous studies, mirror therapy, and contralateral strength training have shown promising results individually, but their direct comparison for both upper and lower limbs remains under-explored in the literature.
The rationale for this study stems from the critical need to understanding the effectiveness of only mirror-therapy performed solely versus mirror-aided treatment coupled with strength training in enhancing motor functionality across both upper and lower limbs can significantly impact rehabilitative protocols.
This research could uncover potential synergies between the two interventions, presenting an opportunity to develop cost effective novel combined approaches that capitalize on their respective strengths. Ultimately, the study's findings have the potential to advance the field of neuroplasticity aided neurorehabilitation and contribute to improved quality of life for individuals dealing with hemiplegia.
- Conditions
- Stroke
- Being tested
- Strength Training, Mirror therapy
- Keywords
- Hemiplegic stroke, strength training AND stroke, Mirror therapy AND stroke, stroke rehabilitation, strength training and mirror therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength TrainingOther
training time will be 30 minutes therapy, once a day, 3 days a week for 8 weeks. were allowed to rest for 3-5 min during each training.
Mirror therapyOther
Participants in the (trial group) mirror and strength training group observed the reflection of the exercising arm and leg in the mirror. Participants in the (control group) strength training only group will exercise without a mirror entirely.
| Study group | Role | What they receive |
|---|---|---|
| Strength Training | Active comparator | Non-hemiplegic lower limb stepping forward training Non-hemiplegic upper limb pulling elastic belt in standing position repeatedly Hemiplegic lower limb stepped over an obstacle or climbed a platform The patients will stretch their arms to touch distant objects in a standing position repeatedly. Receives: Other: Strength Training |
| Mirror Therapy and strength Training Group | Experimental | Participants in the (trial group) mirror and strength training group observed the reflection of the exercising arm and leg in the mirror. Participants in the (control group) strength training only group will exercise without a mirror entirely. Receives: Other: Strength Training; Other: Mirror therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Barthel Index
MBI is a five-level rating scale, including evaluation of bathing, grooming, feeding, dressing, bowels, bladder, toilet, stairs, chair/bed transfers, and walking. Higher scores represent higher degree of ADL independence. MBI was an efficient, reliable, and valid assessment of ADL for stroke patients.
Measured: 8 weeks
Dynamic Gait Index
Dynamic Gait Index (DGI) is a performance-based tool that quantifies the dynamic balance instability developed by Shumway-Cook and Woollacott, evaluates the ability of the individual to modify gait in response to changing functions during walking.
Measured: 8 weeks
Berg Balance Scale
Consists of 14 tasks and total score of 56.score of 0-20 indicates severe fall risk, 20-45 includes moderate risk of fall and 45-60 illustrates thr functional balances state.
Measured: 8 weks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start10 Mar 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Model description
- 2 groups 1. Strength training only group 2. strength training and mirror therapy group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Aabroo Aabroo, Nmpt, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292403
- Sponsor's protocol ID
- Farwa Akhtar
- Status last verified
- Mar 2024
- First submitted
- 24 Nov 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strength Training of Non-paretic Upper and Lower Limb With or Without Mirror Therapy on Motor Function Recovery of the Pareytic Side in Stroke Patients.
- ClinicalTrials.gov ID
- NCT06292403
- Acronym / sponsor ID
- Farwa Akhtar
- Conditions
- Stroke
- Keywords
- Hemiplegic stroke, strength training AND stroke, Mirror therapy AND stroke, stroke rehabilitation, strength training and mirror therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 5 Mar 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 this study is to find the effects of strength training with or without mirror therapy of non-paralytic upper limb for functional activities and in lower limb for gait pattern, balance and stability, and ADLs of paralytic side in patients with acute and sub-acute stroke. A randomized controlled trial that will include total 44 participants .The control group will undergo usual rehabilitation training along with strength training. The trial group will undergo strength training and mirror therapy of NHS on the basis of usual rehabilitation training. For the control group, training time will be 30 minutes, once a day, 3 days a week for 8 weeks. IN trial group, training time will be 30 minutes therapy, once a day, 3 days a week for 8 weeks. were allowed to rest for 3-5 min during each training. Data collected will be analyzed through SPSS 25.
Detailed description
Stroke is defined as rapidly developing clinical signs of focal or global cerebral function disturbance that lasts more than 24 hours or leads to death, with no other apparent cause than that of vascular origin. Hemiplegia shows one side of the body paralysis involving one upper and one lower extremity. The term hemiplegia is often used generically to refer to the wide variety of motor problems that result from stroke.There are several stroke rehabilitation strategies for UL motor impairment including strength training and mirror therapy.
The idea is to re-educate the brain through a simple task, in which the individual performs a series of movements with the healthy arm, which is reflected in the mirror as if it was the injured arm. In this way, the reflex in the mirror of the healthy arm tricks the brain in believing that the injured arm is functioning as it should before the stroke. Isokinetic strengthening may provide motor and functional improvement in paretic upper extremity among patients with post-stroke hemiplegia. This strategy makes use of the brain's adaptability to enhance motor function after a stroke .
Monika Ehrensberger et al (2019) in a study concluded potential effectiveness of mirror-aided cross-education was undertaken and results portray that, in the case of training isometrically, cross-education was not augmented by mirror therapy. (The effectiveness of strength training of the NHS is evidenced in terms of promoting recovery in patients with stroke experiencing balance, mobility, and muscle strength of the paretic side .
Chenlan Shao et al (2022) conducted his study on the effect of strength training of the non-hemiplegic side (NHS) on balance function, mobility, and muscle strength of patients with stroke. He concluded that Strength training of the NHS can promote recovery of balance, mobility, and muscle strength of the paretic side of patients with stroke.
Harris et al demonstrated that leg weakness develops on the non hemiplegic side (NHS) in the first week after acute stroke. This decline in NHS muscle strength must not be ignored in patients with stroke, because it is highly associated with functional performance, and it can be used as an independent predictor of short-term functional gain and outcomes after stroke.
The previous study investigated the feasibility and potential effectiveness of mirror-aided cross-education compared with cross-education alone in post stroke upper limb recovery only. In addition, previous studies, mirror therapy, and contralateral strength training have shown promising results individually, but their direct comparison for both upper and lower limbs remains under-explored in the literature.
The rationale for this study stems from the critical need to understanding the effectiveness of only mirror-therapy performed solely versus mirror-aided treatment coupled with strength training in enhancing motor functionality across both upper and lower limbs can significantly impact rehabilitative protocols.
This research could uncover potential synergies between the two interventions, presenting an opportunity to develop cost effective novel combined approaches that capitalize on their respective strengths. Ultimately, the study's findings have the potential to advance the field of neuroplasticity aided neurorehabilitation and contribute to improved quality of life for individuals dealing with hemiplegia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 2 groups 1. Strength training only group 2. strength training and mirror therapy group
| Arm | Type | Receives |
|---|---|---|
| Strength Training | Active comparator | Other: Strength TrainingNon-hemiplegic lower limb stepping forward training Non-hemiplegic upper limb pulling elastic belt in standing position repeatedly Hemiplegic lower limb stepped over an obstacle or climbed a platform The patients will stretch their arms to touch distant objects in a standing position repeatedly. |
| Mirror Therapy and strength Training Group | Experimental | Other: Strength Training, Other: Mirror therapyParticipants in the (trial group) mirror and strength training group observed the reflection of the exercising arm and leg in the mirror. Participants in the (control group) strength training only group will exercise without a mirror entirely. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Girls aged 17-24 years with regular --Menstrual cycle
- Unmarried girls
Key exclusion criteria (5 listed)
- Athletes
- Married women
- Girls who were regularly exercising
- Having any pelvic pathology
- Abnormal menstrual cycle.
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 |
|---|---|---|
| Strength Trainingtraining time will be 30 minutes therapy, once a day, 3 days a week for 8 weeks. were allowed to rest for 3-5 min during each training. | Other | Mirror Therapy and strength Training Group, Strength Training |
| Mirror therapyParticipants in the (trial group) mirror and strength training group observed the reflection of the exercising arm and leg in the mirror. Participants in the (control group) strength training only group will exercise without a mirror entirely. | Other | Mirror Therapy and strength Training Group |
Primary outcome
Modified Barthel Index
Time frame: 8 weeks
MBI is a five-level rating scale, including evaluation of bathing, grooming, feeding, dressing, bowels, bladder, toilet, stairs, chair/bed transfers, and walking. Higher scores represent higher degree of ADL independence. MBI was an efficient, reliable, and valid assessment of ADL for stroke patients.
Dynamic Gait Index
Time frame: 8 weeks
Dynamic Gait Index (DGI) is a performance-based tool that quantifies the dynamic balance instability developed by Shumway-Cook and Woollacott, evaluates the ability of the individual to modify gait in response to changing functions during walking.
Berg Balance Scale
Time frame: 8 weks
Consists of 14 tasks and total score of 56.score of 0-20 indicates severe fall risk, 20-45 includes moderate risk of fall and 45-60 illustrates thr functional balances state.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Sara Aabroo Aabroo, Nmpt 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 Strength Training and Mirror therapy 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 2 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 5 Mar 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 Sara Aabroo Aabroo, Ms NMPT (03155185508, sara.aabroo@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Barthel Index (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2024.