Stroke, IschemicNCT05429944
MRP and PNF Effect on Upper Limb Motor Performance and Quality of Life in Sub-acute Stroke
A study testing Motor Relearning Program, Proprioceptive Neuromuscular Facilitation and Conventional Physical Therapy in people with Stroke, Ischemic, run by Riphah International University at 1 site in Pakistan.
Trial summary
Through this study we compare the the effects of motor relearning program and proprioceptive neuromuscular facilitation on upper limb motor performance and quality of life in sub-acute stroke survivors. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Motor Relearning Program, Proprioceptive Neuromuscular Facilitation and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2022to 28 Feb 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40-70 years are included.
- Both genders are included
- Hemiplegic ischemic stroke of both sides
- Participants with sub-acute Stroke (from 1 week to 6 months).
- Non- aphasic stroke patients.
- Clinically stable patients.
Who cannot join
- Recurrent Stroke
- Patients with other neurological conditions and deficits.
- Patients with other orthopedic condition like frozen shoulder or unhealed fracture of upper limb.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Motor Relearning Program and Proprioceptive Neuromuscular Facilitation on Upper Limb Motor Performance and Quality of Life in Sub-acute Stroke Survivors
Through this study we compare the the effects of motor relearning program and proprioceptive neuromuscular facilitation on upper limb motor performance and quality of life in sub-acute stroke survivors. This study will be a randomized controlled trial will recruit a sample of 39 participants through non-probability consecutive sampling technique. After satisfying the inclusion criteria, participants will be divided into three groups. The first group will receive motor relearning program for 6 weeks, 3 times per week for 30 minutes, along with the conventional therapy. The second group will receive proprioceptive neuromuscular facilitation for 6 weeks, 3 times per week for 30 minutes, along with conventional therapy. The third group will only receive conventional the conventional therapy.
Read the detailed description
One study revealed that both PNF and CIMT were effective in the management of upper limb chronic post- stroke patients. However, CIMT is the preferred technique for upper limb function recovery.
Another experimental study was conducted on comparison between proprioceptive neuromuscular facilitation versus mirror therapy enhances gait and balance in paretic lower limb in acute stroke. In this study patients are randomly divided into two groups. According to statistical analysis this study shows that both the techniques Group A (Proprioceptive Neuromuscular Facilitation) and Group B (Mirror Therapy) were individually effective in improving gait and balance. While comparing both the techniques there is a significant difference present in the group. So, Group A is more effective in enhancing gait and balance in paretic lower limb after acute Stroke.
Another randomized control trial was conducted on comparing the effects of motor relearning programs and mirror therapy for improving upper limb motor function in stroke patient. This study concluded that MRP and MT were found to be effective in improving upper limb motor function of stroke patients, but the former was more effective than the later.
Another comparative study was conducted on motor relearning program versus proprioceptive neuro-muscular facilitation technique for improving basic mobility in chronic stroke patients- According to the results he concluded that MRP is more effective then PNF for improving basic mobility of sit to stand and walking in chronic stroke subjects and subjects were able to maintain their basic mobility at one month follow up also.
Previous studies have compared only a single intervention with controls; however, this study aims to compare two different interventions in addition to comparison with the control groups.
All these interventions previously used focus on the functional activities as a training component after stroke and have shown some degree of improvement in the functional outcome of the upper limb, but still, there is a paucity of literature on which intervention improves motor performance in an optimum timeframe during the subacute phase of stroke.
Given this gap in the literature, a study is needed to elucidate the comparative effects of motor relearning program and proprioceptive neuromuscular facilitation on upper limb motor performance and quality of life in sub-acute stroke survivors.
- Conditions
- Stroke, Ischemic
- Being tested
- Motor Relearning Program, Proprioceptive Neuromuscular Facilitation, Conventional Physical Therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Relearning ProgramOther
The exercise will be performed for approximately 30 minutes, 3 times a week for 6 weeks.
Proprioceptive Neuromuscular FacilitationOther
The techniques administered included Rhythmic Initiation, Slow Reversal and Agonistic Reversal.
The exercise will be performed for approximately 30 minutes, 3 times a week for 6 weeks.
Conventional Physical TherapyOther
The exercise will be performed for approximately 30 minutes, 3 times a week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Motor Relearning Program | Experimental | MRP is a task- oriented approach to improve motor control, focusing on relearning of daily activities. Based on 4 steps
1.Analysis of task 2.Practice of missing component 3.Practice of task 4.Transference of learning Receives: Other: Motor Relearning Program |
| Proprioceptive Neuromuscular Facilitation | Experimental | Proprioceptive Neuromuscular Facilitation (PNF) is the neurophysiological approach in which impulses from the periphery are facilitated to the central nervous system through the stimulation of sensory receptors present in muscles and around the joints by stretch, resistance, traction, approximation and audiovisual command to the patient. The techniques administered included Rhythmic Initiation, Slow Reversal and Agonistic Reversal. Receives: Other: Proprioceptive Neuromuscular Facilitation |
| Conventional Physical Therapy | Active comparator | Electrotherapy includes TENS, Electrical stimulation and Heat therapy. ROM . Stretching and positioning Exercises Strengthening Exercises for the weak muscles. Sensory Interventions. Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Changes from baseline The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. The motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand. Each item consists of a 3- point scale (0, 1, and 2), with a total maximum score of 66.
Measured: 6 weeks
Secondary outcomes (3)
Modified Ashworth Scale (MAS)
It is used to assess spasticity. its performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension the point at which the first soft resistance is met. Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion.
Measured: 6 weeks
Motor Assessment Scale
The MAS was originally designed to assess eight subsets of motor function and one subset of muscle tone. The upper limb subscale (UL-MAS) consists of subset 6: 'Upper Arm Activity', subset 7: 'Hand Movements', and subset 'Advanced Hand Activities'.
Measured: 6 weeks
Stroke Impact Scale
It is a stroke-specific, self-report, health status measure. It was designed to assess multidimensional Stroke outcomes, including strength, hand function Activities of Daily Living/ Instrumental Activities of Daily Living (ADL/IADL), mobility, communication, emotion, memory and thinking, and participation.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start15 Jun 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Aabroo, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429944
- Sponsor's protocol ID
- REC//22/0203 Tabeer Sheikh
- Status last verified
- Jul 2023
- First submitted
- 20 Jun 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guiu-Tula FX, Cabanas-Valdes R, Sitja-Rabert M, Urrutia G, Gomara-Toldra N. The Efficacy of the proprioceptive neuromuscular facilitation (PNF) approach in stroke rehabilitation to improve basic activities of daily living and quality of life: a systematic review and meta-analysis protocol. BMJ Open. 2017 Dec 12;7(12):e016739. doi: 10.1136/bmjopen-2017-016739.
PubMed 29233831Ullah I, Arsh A, Zahir A, Jan S. Motor relearning program along with electrical stimulation for improving upper limb function in stroke patients: A quasi experimental study. Pak J Med Sci. 2020 Nov-Dec;36(7):1613-1617. doi: 10.12669/pjms.36.7.2351.
PubMed 33235584Batool S, Soomro N, Amjad F, Fauz R. To compare the effectiveness of constraint induced movement therapy versus motor relearning programme to improve motor function of hemiplegic upper extremity after stroke. Pak J Med Sci. 2015 Sep-Oct;31(5):1167-71. doi: 10.12669/pjms.315.7910.
PubMed 26649007Jan S, Arsh A, Darain H, Gul S. A randomized control trial comparing the effects of motor relearning programme and mirror therapy for improving upper limb motor functions in stroke patients. J Pak Med Assoc. 2019 Sep;69(9):1242-1245.
PubMed 31511706Diaz-Arribas MJ, Martin-Casas P, Cano-de-la-Cuerda R, Plaza-Manzano G. Effectiveness of the Bobath concept in the treatment of stroke: a systematic review. Disabil Rehabil. 2020 Jun;42(12):1636-1649. doi: 10.1080/09638288.2019.1590865. Epub 2019 Apr 24.
PubMed 31017023Bai Z, Zhang J, Zhang Z, Shu T, Niu W. Comparison Between Movement-Based and Task-Based Mirror Therapies on Improving Upper Limb Functions in Patients With Stroke: A Pilot Randomized Controlled Trial. Front Neurol. 2019 Mar 26;10:288. doi: 10.3389/fneur.2019.00288. eCollection 2019.
PubMed 30972016Singer B, Garcia-Vega J. The Fugl-Meyer Upper Extremity Scale. J Physiother. 2017 Jan;63(1):53. doi: 10.1016/j.jphys.2016.08.010. Epub 2016 Oct 17. No abstract available.
PubMed 27964964Pickering RL, Hubbard IJ, Baker KG, Parsons MW. Assessment of the upper limb in acute stroke: the validity of hierarchal scoring for the Motor Assessment Scale. Aust Occup Ther J. 2010 Jun;57(3):174-82. doi: 10.1111/j.1440-1630.2009.00810.x.
PubMed 20854586
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Motor Relearning Program and Proprioceptive Neuromuscular Facilitation on Upper Limb Motor Performance and Quality of Life in Sub-acute Stroke Survivors
- ClinicalTrials.gov ID
- NCT05429944
- Acronym / sponsor ID
- REC//22/0203 Tabeer Sheikh
- Conditions
- Stroke, Ischemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 23 Jun 2022 (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.
Through this study we compare the the effects of motor relearning program and proprioceptive neuromuscular facilitation on upper limb motor performance and quality of life in sub-acute stroke survivors. This study will be a randomized controlled trial will recruit a sample of 39 participants through non-probability consecutive sampling technique. After satisfying the inclusion criteria, participants will be divided into three groups. The first group will receive motor relearning program for 6 weeks, 3 times per week for 30 minutes, along with the conventional therapy. The second group will receive proprioceptive neuromuscular facilitation for 6 weeks, 3 times per week for 30 minutes, along with conventional therapy. The third group will only receive conventional the conventional therapy.
Detailed description
One study revealed that both PNF and CIMT were effective in the management of upper limb chronic post- stroke patients. However, CIMT is the preferred technique for upper limb function recovery.
Another experimental study was conducted on comparison between proprioceptive neuromuscular facilitation versus mirror therapy enhances gait and balance in paretic lower limb in acute stroke. In this study patients are randomly divided into two groups. According to statistical analysis this study shows that both the techniques Group A (Proprioceptive Neuromuscular Facilitation) and Group B (Mirror Therapy) were individually effective in improving gait and balance. While comparing both the techniques there is a significant difference present in the group. So, Group A is more effective in enhancing gait and balance in paretic lower limb after acute Stroke.
Another randomized control trial was conducted on comparing the effects of motor relearning programs and mirror therapy for improving upper limb motor function in stroke patient. This study concluded that MRP and MT were found to be effective in improving upper limb motor function of stroke patients, but the former was more effective than the later.
Another comparative study was conducted on motor relearning program versus proprioceptive neuro-muscular facilitation technique for improving basic mobility in chronic stroke patients- According to the results he concluded that MRP is more effective then PNF for improving basic mobility of sit to stand and walking in chronic stroke subjects and subjects were able to maintain their basic mobility at one month follow up also.
Previous studies have compared only a single intervention with controls; however, this study aims to compare two different interventions in addition to comparison with the control groups.
All these interventions previously used focus on the functional activities as a training component after stroke and have shown some degree of improvement in the functional outcome of the upper limb, but still, there is a paucity of literature on which intervention improves motor performance in an optimum timeframe during the subacute phase of stroke.
Given this gap in the literature, a study is needed to elucidate the comparative effects of motor relearning program and proprioceptive neuromuscular facilitation on upper limb motor performance and quality of life in sub-acute stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motor Relearning Program | Experimental | Other: Motor Relearning ProgramMRP is a task- oriented approach to improve motor control, focusing on relearning of daily activities. Based on 4 steps 1.Analysis of task 2.Practice of missing component 3.Practice of task 4.Transference of learning |
| Proprioceptive Neuromuscular Facilitation | Experimental | Other: Proprioceptive Neuromuscular FacilitationProprioceptive Neuromuscular Facilitation (PNF) is the neurophysiological approach in which impulses from the periphery are facilitated to the central nervous system through the stimulation of sensory receptors present in muscles and around the joints by stretch, resistance, traction, approximation and audiovisual command to the patient. The techniques administered included Rhythmic Initiation, Slow Reversal and Agonistic Reversal. |
| Conventional Physical Therapy | Active comparator | Other: Conventional Physical TherapyElectrotherapy includes TENS, Electrical stimulation and Heat therapy. ROM . Stretching and positioning Exercises Strengthening Exercises for the weak muscles. Sensory Interventions. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 40-70 years are included.
- Both genders are included
- Hemiplegic ischemic stroke of both sides
- Participants with sub-acute Stroke (from 1 week to 6 months).
- Non- aphasic stroke patients.
Key exclusion criteria (3 listed)
- Recurrent Stroke
- Patients with other neurological conditions and deficits.
- Patients with other orthopedic condition like frozen shoulder or unhealed fracture of upper limb.
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 ProgramThe exercise will be performed for approximately 30 minutes, 3 times a week for 6 weeks. | Other | Motor Relearning Program |
| Proprioceptive Neuromuscular FacilitationThe techniques administered included Rhythmic Initiation, Slow Reversal and Agonistic Reversal. The exercise will be performed for approximately 30 minutes, 3 times a week for 6 weeks. | Other | Proprioceptive Neuromuscular Facilitation |
| Conventional Physical TherapyThe exercise will be performed for approximately 30 minutes, 3 times a week for 6 weeks. | Other | Conventional Physical Therapy |
Primary outcome
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Time frame: 6 weeks
Changes from baseline The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. The motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand. Each item consists of a 3- point scale (0, 1, and 2), with a total maximum score of 66.
3 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: 6 weeks
Motor Assessment Scale
Time frame: 6 weeks
Stroke Impact Scale
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 29233831Guiu-Tula FX, Cabanas-Valdes R, Sitja-Rabert M, Urrutia G, Gomara-Toldra N. The Efficacy of the proprioceptive neuromuscular facilitation (PNF) approach in stroke rehabilitation to improve basic activities of daily living and quality of life: a systematic review and meta-analysis protocol. BMJ Open. 2017 Dec 12;7(12):e016739. doi: 10.1136/bmjopen-2017-016739.
- Background: PubMed 33235584Ullah I, Arsh A, Zahir A, Jan S. Motor relearning program along with electrical stimulation for improving upper limb function in stroke patients: A quasi experimental study. Pak J Med Sci. 2020 Nov-Dec;36(7):1613-1617. doi: 10.12669/pjms.36.7.2351.
- Background: PubMed 26649007Batool S, Soomro N, Amjad F, Fauz R. To compare the effectiveness of constraint induced movement therapy versus motor relearning programme to improve motor function of hemiplegic upper extremity after stroke. Pak J Med Sci. 2015 Sep-Oct;31(5):1167-71. doi: 10.12669/pjms.315.7910.
- Background: PubMed 31511706Jan S, Arsh A, Darain H, Gul S. A randomized control trial comparing the effects of motor relearning programme and mirror therapy for improving upper limb motor functions in stroke patients. J Pak Med Assoc. 2019 Sep;69(9):1242-1245.
- Background: PubMed 31017023Diaz-Arribas MJ, Martin-Casas P, Cano-de-la-Cuerda R, Plaza-Manzano G. Effectiveness of the Bobath concept in the treatment of stroke: a systematic review. Disabil Rehabil. 2020 Jun;42(12):1636-1649. doi: 10.1080/09638288.2019.1590865. Epub 2019 Apr 24.
- Background: PubMed 30972016Bai Z, Zhang J, Zhang Z, Shu T, Niu W. Comparison Between Movement-Based and Task-Based Mirror Therapies on Improving Upper Limb Functions in Patients With Stroke: A Pilot Randomized Controlled Trial. Front Neurol. 2019 Mar 26;10:288. doi: 10.3389/fneur.2019.00288. eCollection 2019.
- Background: PubMed 27964964Singer B, Garcia-Vega J. The Fugl-Meyer Upper Extremity Scale. J Physiother. 2017 Jan;63(1):53. doi: 10.1016/j.jphys.2016.08.010. Epub 2016 Oct 17. No abstract available.
- Background: PubMed 20854586Pickering RL, Hubbard IJ, Baker KG, Parsons MW. Assessment of the upper limb in acute stroke: the validity of hierarchal scoring for the Motor Assessment Scale. Aust Occup Ther J. 2010 Jun;57(3):174-82. doi: 10.1111/j.1440-1630.2009.00810.x.
- 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.
Sara Aabroo, MS 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, Proprioceptive Neuromuscular Facilitation and Conventional Physical Therapy in people with Stroke, Ischemic, 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 1 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment Upper Extremity (FMA-UE) (time frame: 6 weeks). 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 NCT05429944, which also lists 8 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 1 Aug 2023.