Comparison of Goal Specific Functional Tasks With and Without Mirror Therapy

NCT04606641 | Completed DMC

• 1 other identifier: REC/00666 Faryal Baig
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The hemiparetic arm is one of the most undesirable consequences of stroke. Approximately 30-66% of patients with stroke are not able to gain motor function of their affected hand which prevents them from performing their daily activities for the rest of their lives. It is very important in the treatment of stroke patients to improve their upper limb function. Mirror therapy has drawn much focus on the rehabilitation of hemiplegic stroke patients in the past two decades. Mirror therapy is one of the priming technique that causes neural plasticity of the brain. In mirror therapy a mirror is placed in the mid-sagittal plane of the patient between his two arms and the patient is given instruction to move his less affected or normal limb while looking at its reflection in the mirror which will produce as the affected or paretic limb is also moving with a normal movement pattern. This will create visual stimulus on the patient's brain known as mirror visual feedback (MVF) and will cause cortical reorganization hence it will increase the motor recovery of the affected or paretic limb. A type of mirror therapy is task-based mirror therapy in which the participants are asked to perform specific motor tasks with their less affected arm. There are very few studies regarding mirror therapy combined with functional tasks. It is a randomized controlled trial study and its duration is 6 months. Total sample size will be 26; 13 participants into each group. The subjects will be divided into two groups, Group A Experimental group and Group B control group. A 20 minutes session will be performed thrice in a week for a total of 6 weeks. The experimental group will perform functional tasks with mirror therapy and the control group will perform functional tasks without mirror therapy. The Standardized Mini-Mental State Examination scale and Brunnstrom stages of motor recovery scale will be used in the inclusion criteria of patients. Outcomes of patients will be measured using Brunnstrom stages of motor recovery, Motor Assessment Scale (MAS) upper limb component, Fugl Meyer Upper Extremity Assessment Scale (FMA-UE) and Functional Independence Measure (FIM) self-care component at baseline, after every 2 weeks and with follow up at 6 weeks. After this, the data will be analyzed on the Statistical Package for the Social Sciences (SPSS) 21 version.

Conditions

Stroke

Keywords

Stroke; Functional Tasks; Mirror Therapy

Outcome Measures

Primary Outcomes (3)

• Fugl-Meyer Assessment-Upper Extremity (FMA-UE)

  The Fugl-Meyer assessment scale (FMA), developed in 1975, has been used to describe the motor and sensory recovery of patients after stroke. It is divided into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. The FMA is a well-designed and efficient clinical examination tool that has been widely used in post stroke patients. Excellent interrater and intrarater reliability and construct validity have been demonstrated score of 0-28 indicate severe , 29-42moderate, and 43-66 mild impairment in upper limb function.

  week 4

• Functional Independence Measure (FIM) Self care component

  The Functional Independence Measure (FIM) is the functional assessment instrument that measures outcomes of rehabilitation. This scale tells about changes in the functional status of the patients from the onset of rehabilitation through dis¬charge and follow-up. High test re test reliability for 45 repeated FIM assessments for the motor and cognitive subscales was demonstrated when used in elderly population The clinician performing the assessment scores each item on a scale of 1 to 7. The higher the score is for a task, the more independent a person is at performing the task.

  week 4

• Brunnstrom Stages of motor recovery

  The brunnstrom stages of motor recovery was designed to describe a sequence of motor recovery of extremity after stroke based on the synergy pattern of movement that develops during recovery from a flaccid limb to near-normal and normal movement and coordination. This scale efficiently assesses the post stroke motor functions Stage 1: Flaccidity. ... Stage 2: Dealing with Spasticity Appearance. ... Stage 3: Increased Spasticity. ... Stage 4: Decreased Spasticity. ... Stage 5: Complex Movement Combinations. ... Stage 6: Spasticity Disappears. ... Stage 7: Normal Function Returns

  week 4

Study Arms (2)

Goal specific functional tasks with mirror therapy):

EXPERIMENTAL

The session will be performed thrice in a week for total of 4 weeks. Each session will last for 20 minutes. Mirror therapy procedure and functional tasks will be explained to the patient before the start of treatment. In this group, a mirror will be placed in the sagittal plane of the patient. The affected or paretic arm will be placed behind the mirror and the unaffected or normal arm will be placed in front of the mirror

Other: functional tasks with mirror therapy

Goal specific functional tasks without mirror therapy

ACTIVE COMPARATOR

Session will be performed thrice in a week for total 4 weeks. Each session will last for 20 minutes. The functional tasks will be explained to patient before the start of treatment. In this group a board instead of a mirror will be placed in the sagittal plane of patient. Then the patient will be asked to perform functional tasks as mentioned in the table below Functional tasks will be same in both groups

Other: functional tasks without mirror therapy

Interventions

functional tasks with mirror therapy OTHER

In this group a mirror will be placed in the sagittal plane of patient. The affected or paretic arm will be placed behind the mirror and the unaffected or normal arm will be placed in front of the mirror. Then the patient will be asked to perform functional tasks

Goal specific functional tasks with mirror therapy):

functional tasks without mirror therapy OTHER

The functional tasks will be explained to patient before the start of treatment. In this group a board instead of a mirror will be placed in the sagittal plane of patient. Then the patient will be asked to perform functional tasks

Goal specific functional tasks without mirror therapy

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemiplegic ischemic or hemorrhagic subacute stroke patients,
• Brunnstrom stages of recovery (2-4) for upper extremity,
• No serious cognitive deficits i-e Standardized mini-mental state examination 24 points or more.

You may not qualify if:

• Neuromuscular or musculoskeletal disease affecting upper limb
• Any traumatic injury to the upper limb
• Hemi spatial neglect
• Participation in any other rehabilitation study

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Fauji Foundation Hospital

Rawalpindi, Pakistan

Location

Related Links

• Traditional Risk Factors for Stroke in East Asia. Journal of Stroke
• Stroke Epidemiology in South, East, and South-East Asia: A Review
• Stroke Epidemiology in South, East, and South-East Asia: A Review. Journal of Stroke
• Sex Differences in Stroke Incidence, Prevalence, Mortality and Disability-Adjusted Life Years: Results from the Global Burden of Disease Study 2013
• Prevalence of Stroke and Vascular Risk Factors in China: a Nationwide Community-based Study. Scientific reports
• Quality of life after stroke in Pakistan. BMC neurology.
• Stroke Prevalence, Mortality and Disability-Adjusted Life Years in Adults Aged 20-64 Years in 1990-2013

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Ayesha Afridi, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 28, 2020
• Study Start: May 1, 2020
• Primary Completion: November 27, 2020
• Study Completion: November 30, 2020
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)