- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05948384
Mirror Therapy Versus PNF on LE Function in Stroke
Comparison of Mirror Therapy and PNF on Lower Extremity Function in Chronic Stroke Patients.
Study Overview
Detailed Description
PNF and mirror therapy has its effect on chronic stroke patients. Both mirror therapy and PNF work on the concept of neuroplasticity. Neuroplasticity is the ability of the nervous system to change its activity in response to intrinsic or extrinsic stimuli by reorganizing its structure, functions, or connections after injuries. Because of brain plasticity, neurorehabilitation has evolved, as evidenced by numerous physiotherapeutic approaches such as proprioceptive neuromuscular facilitation (PNF) and mirror treatment (MT). The reorganization also includes the expansion of cortical regions, which offer the neural foundation for the recovery or adaption of motor activity following injury.
As the literature supports the individual effects of both techniques in stroke population but as per author's access, there is no literature provide the comparison among both techniques i.e. PNF and mirror therapy in lower limb for chronic stroke patients on gait and functionality. Hence the author established the research question that is there any difference among these techniques in stroke population in terms of its effects and efficiency on gait and functionality. The study will provide an insight to the clinician about which technique has the superior/ better effects for the lower extremity functions in chronic stroke patients thus telling the effects two neurorehabilitation methods i.e. proprioceptive neuromuscular facilitation (PNF) and mirror therapy (MT).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shahnoor Syed, DPT
- Phone Number: 00923450251377
- Email: shahnoor304@gmail.com
Study Contact Backup
- Name: Mirza Obaid Baig, MSPT
- Phone Number: 00923332238706
- Email: obaid.baig@riphah.edu.pk
Study Locations
-
-
Khyber Pakhtunkhwa
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Abbottābād, Khyber Pakhtunkhwa, Pakistan
- Women Institute of Rehabilitation Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both male and female
- ACA stroke
- Ischemic and hemorrhagic stroke
- MMSE grade >24
- Spasticity at modified Ashworth scale between 1 and 2
- Modified Rankin scale 4
Exclusion Criteria:
- Any orthopedic impairment of lower extremity like LLD, fractures, dislocations, amputations, deformity of joint
- Any other neurological condition (multiple sclerosis, Parkinson disease, SCI)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PNF Group
For the PNF intervention, we applied a lower extremity hip extension-abduction-internal rotation with knee extension pattern, together with the rhythmic initiation of a repeated stretch and a combination of isotonic techniques.
By this we'll target rectus femoris, medial gastrocnemius, lateral gastrocnemius, biceps femoris and semitendinosus musculature of the patient.
The session will be given in 2 sets of 5 repetitions with rest of 45 seconds
|
For the PNF intervention, we applied a lower extremity hip extension-abduction-internal rotation with knee extension pattern, together with the rhythmic initiation of a repeated stretch and a combination of isotonic techniques.
By this we'll target rectus femoris, medial gastrocnemius, lateral gastrocnemius, biceps femoris and semitendinosus musculature of the patient.
The session will be given in 2 sets of 5 repetitions with rest of 45 seconds
|
Other: Mirror Therapy Group
Mirror treatment is a sort of motor imagery in which the patient exercises his unaffected limb while looking at himself in the mirror.
It involves placing the affected limb behind a mirror.
The mirror is positioned so the reflection of the opposing limb appears in place of the hidden limb.
The patient then looks into the mirror on the side with unaffected limb and makes "mirror symmetric" movement.
It will implemented for about 30 minutes with 2, 2 minutes rest in between.
Patient will perform as many repetitions as they could of knee flexion & extension, ankle dorsiflexion & plantarflexion and functional tasks (rolling the foot over the roller, reaching would be accomplished by asking the patient to reach towards objects through his leg e.g.
touching the feet to a certain object at a particular height and distance, cycling) depending on patient's ability to do so.
|
For the PNF intervention, we applied a lower extremity hip extension-abduction-internal rotation with knee extension pattern, together with the rhythmic initiation of a repeated stretch and a combination of isotonic techniques.
By this we'll target rectus femoris, medial gastrocnemius, lateral gastrocnemius, biceps femoris and semitendinosus musculature of the patient.
The session will be given in 2 sets of 5 repetitions with rest of 45 seconds
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lower extremity functional scale
Time Frame: 8 week
|
a reliable patient-rated outcome measure for assessing lower extremity function.
This is a 20-item self-report questionnaire.
The highest attainable score is 80 points, signifying excellent function.
The lowest possible score is 0, indicating very poor function.
It has an outstanding internal reliability (=0.96) and a valid tool.
It will be measured at baseline, 4th and 8th week
|
8 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dynamic gait index
Time Frame: 8 week
|
It assesses the participant's ability to maintain walking balance while reacting to varied task demands under diverse dynamic settings.
It is a beneficial test for those who have vestibular and balance issues, as well as those who are at danger of falling.
It will be measured at baseline, 4th and 8th week
|
8 week
|
Time Up and Go Test
Time Frame: 8 week
|
Time up and go test is a quick and widely used clinical performance-based measure of lower extremity function, mobility and fall risk with a specificity of 0.70 and sensitivity of 0.57 and reliability of 0.98.The higher the score reflects the worst functional status.
It will be measured at baseline, 4th and 8th week
|
8 week
|
Stroke Specific Quality of Life Scale
Time Frame: 8 week
|
It is a patient-centered outcome measure designed to assess health-related quality of life in stroke patients.
Patients must answer each question with a reference to the previous week.
It is a self-report measure with 49 items divided into 12 areas.
A 5-point Likert scale is used to rate the items.
The Cronbach alpha ranged from 0.75-0.89.
It will be measured at baseline, 4th and 8th week
|
8 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mirza Obaid Baig, MSPT, Riphah International University
Publications and helpful links
General Publications
- Sherin A, Ul-Haq Z, Fazid S, Shah BH, Khattak MI, Nabi F. Prevalence of stroke in Pakistan: Findings from Khyber Pakhtunkhwa integrated population health survey (KP-IPHS) 2016-17. Pak J Med Sci. 2020 Nov-Dec;36(7):1435-1440. doi: 10.12669/pjms.36.7.2824.
- 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.
- Amarenco P. Transient Ischemic Attack. N Engl J Med. 2020 May 14;382(20):1933-1941. doi: 10.1056/NEJMcp1908837. No abstract available.
- Gandhi DB, Sterba A, Khatter H, Pandian JD. Mirror Therapy in Stroke Rehabilitation: Current Perspectives. Ther Clin Risk Manag. 2020 Feb 7;16:75-85. doi: 10.2147/TCRM.S206883. eCollection 2020.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC01540 Shahnoor Syed
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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