Clinical trial NCT04468945: Mirror Therapy Versus Repetitive Facilitation Exercise on Upper Limb Function
Official title: Effects of Mirror Therapy Versus Repetitive Facilitation Exercise on Upper Limb Function in Post-stroke Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Patient
Keywords: Mirror therapy
Repetitive Facilitation Exercise
stroke
Upper limb
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to determine the effects of Mirror therapy on upper limb function in a post-stroke patient, To determine the effects of Repetitive Facilitation Exercise on upper limb function in a post-stroke patient and To compare the effects of Mirror therapy versus Repetitive Facilitation Exercise on upper limb function in the post-stroke patient. Study Design is Randomized control trial with a sample size of 50 participants. Sampling Technique used is Non-probability purposive assessor-blinded sampling technique and randomization through sealed envelope method Duration of study was 6 months.Study Setting of Railway general hospital. Inclusion criteria had Hemiparetic patient, Sub-acute and chronic stroke patients, First-ever stroke patient, Age: 40-60, Gender: both male and female, MMSE \>24, Modified Ashworth scale \<3, Stable patient (Good sitting balance ) and No visual-spatial hemineglect. Exclusion criteria of Unstable patient, Uncooperative patient, Orthopedic deformity, Aphasia, Visual infection and joint pain (shoulder, elbow, wrist, hip, knee, ankle)

Detailed description: Stroke is classically characterized as a neurological deficit attributed to an acute focal injury of the central nervous system by a vascular cause, including cerebral infarction, intracerebral haemorrhage, and subarachnoid haemorrhage, and is a major cause of disability and death worldwide. Stroke is the second leading cause of death and the third leading cause of disability. Stroke, the sudden death of some brain cells due to lack of oxygen when the blood flow to the brain is lost by blockage or rupture of an artery to the brain, is also a leading cause of dementia and depression. Stroke kills about 140,000 Americans each year that's 1 out of every 20 deaths. In Pakistan, the stroke incidence of 95 per 100,000 persons per year for the following Years 2000 to 2016, with the highest incidence being 584,000 of 650,000, noted among individuals aged 75 to 85. The paretic upper limb is a common and undesirable consequence of stroke that increases activity limitation. A number of interventions have been published evaluating the effect of various rehabilitation methods improving upper extremity control and functioning. Mirror therapy is a relatively new therapeutic intervention which is simple, inexpensive and most importantly patient-directed treatment that focuses on moving the unimpaired limb. It was first introduced by Ramachandran and Roger Ramachandran to treat phantom limb pain after amputation.The principle of mirror therapy (MT) is use of a mirror to create reflective illusion of an affected limb in order to trick the brain into thinking movement has occurred without pain. It involves placing the affected limb behind a mirror, which is sited to the reflection of the opposing limb appears in placing of the hidden limb. During performing the tasks with the unaffected hand, the participants were instructed to move their affected arm synchronically in the same way while viewing the mirror during the practices with the unaffected arm, the participants were instructed to move their affected arm synchronically while viewing the mirror. Repetitive facilitative exercise (RFE), a combination of high repetition rate and neuro facilitation, is a recently developed approach to the rehabilitation of stroke-related limb impairment. The RFE sessions used a novel facilitation technique to elicit movements of the shoulder, elbow and each finger isolated from synergy and give sufficient physical stimulation, such as by the stretch reflex or skin-muscle reflex that is elicited immediately before or at the same time as when the patient makes an effort to move his hemiplegic hand or finger. Functional recovery of the hemiplegic upper limb and hand might depend on the repetition of voluntary movements elicited by the RFEs, especially when they are influenced by a synergistic pattern. Principles for selection and treatment included the following: (1) an emphasis on the proximal musculature, given its role in stabilizing distal movements, gradual increases in movement difficulty with a goal of maintaining movement purity and avoiding synergy; and consideration of the importance/nature of the movement (eg, the first and second fingers were trained separately and the third and fourth together to facilitate the acquisition of pinch. This aim of the study is to improve the function of the upper limb in post-stroke hemiparesis patient. Repetitive Facilitation exercise has proved beneficial effects for improving upper limb function on stroke patients. There is also different opinion about the effectiveness of Mirror therapy on upper limb function. So the purpose of my study is to investigate whether Mirror Therapy or Repetitive Facilitation exercise is more effective in improving upper limb function in Stroke patients.

Eligibility criteria: Inclusion Criteria:

* Hemiparetic patient
* Sub-acute and chronic stroke patients
* First-ever stroke patient
* Age: 40-60
* Gender: both male and female
* MMSE \>24
* Modified Ashworth scale \<3
* Stable patient (Good sitting balance )
* No visual-spatial hemineglect.

Exclusion Criteria:

* Unstable patient
* Uncooperative patient
* Orthopaedic deformity
* Aphasia
* Visual infection
* Joint pain (shoulder, elbow, wrist, hip, knee, ankle)

Primary outcomes:
measure: Fugal Meyer scale
timeFrame: From baseline to 6th week
measure: Wolf motor scale
timeFrame: From baseline to 6th week
measure: Upper extremity functional index
timeFrame: From baseline to 6th week
measure: Brunnstrom scale
timeFrame: From baseline to 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
Study officials:
affiliation: Riphah International University
name: Aruba Saeed, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
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