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Mirror Therapy Versus PNF on LE Function in Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
PNF
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Women Institute of Rehabilitation SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

PNF Group

Mirror Therapy Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Lower extremity functional scale
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

Secondary Outcome Measures

Dynamic gait index
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
Time Up and Go Test
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
Stroke Specific Quality of Life Scale
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

Full Information

First Posted
July 7, 2023
Last Updated
August 18, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05948384
Brief Title
Mirror Therapy Versus PNF on LE Function in Stroke
Official Title
Comparison of Mirror Therapy and PNF on Lower Extremity Function in Chronic Stroke Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Many rehabilitation strategies are being implemented to treat stroke. Constraint-induced movement therapy and robotics are two potentially useful treatment options for rehabilitation. Range of motion exercises, PNF, mirror therapy is also used. Fitness training, high-intensity treatment, and repetitive-task training are all promising strategies that might help improve elements of gait. Repeated task training may also help with transfer functions
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PNF Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Mirror Therapy Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PNF
Intervention Description
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
Primary Outcome Measure Information:
Title
Lower extremity functional scale
Description
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
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Dynamic gait index
Description
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
Time Frame
8 week
Title
Time Up and Go Test
Description
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
Time Frame
8 week
Title
Stroke Specific Quality of Life Scale
Description
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
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahnoor Syed, DPT
Phone
00923450251377
Email
shahnoor304@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mirza Obaid Baig, MSPT
Phone
00923332238706
Email
obaid.baig@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirza Obaid Baig, MSPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women Institute of Rehabilitation Sciences
City
Abbottābād
State/Province
Khyber Pakhtunkhwa
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahnoor Syed, DPT
Phone
0092 345 0251377
Email
shahnoorsyed304@gmail.com
First Name & Middle Initial & Last Name & Degree
Mirza Obaid Baig, MSPT
Phone
0092 333 2238706
Email
obaid.baig@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32402163
Citation
Amarenco P. Transient Ischemic Attack. N Engl J Med. 2020 May 14;382(20):1933-1941. doi: 10.1056/NEJMcp1908837. No abstract available.
Results Reference
background
PubMed Identifier
33235553
Citation
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.
Results Reference
background
PubMed Identifier
29233831
Citation
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.
Results Reference
background
PubMed Identifier
32103968
Citation
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.
Results Reference
background

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Mirror Therapy Versus PNF on LE Function in Stroke

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