Mirror Therapy vs Cross Education Non Paretic Limb Training on Strength and Hand Dexterity in Stroke Survivors.

NCT06059755 | Unknown

• 1 other identifier: RiphahIU Kainat Rashid
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

A stroke is a significant contributor to functional decline and long-term disability. The reduction of obesity and improvement in quality of life are directly correlated. Many post-stroke patients experience persistent upper extremity dysfunction. The study aims to compare cross-education non-paretic limb training versus mirror therapy on upper limb strength and dexterous movement of hand in stroke survivors This randomized clinical trial will be conducted at DHQ Hospital Sargodha over a duration of six months. The sample size will consist of 26 participants. Participants which meet the inclusion criteria will be selected through Non probability convenience sampling technique, which will further be randomized through computer engendered in blocks by using basic number generator.13 participants will be assigned to Cross education group and 13 participants will be assigned to Mirror Therapy group. Data will be using various assessment tools, including the Action Research Arm Test (ARAT) for functional limitation, Fugl-Meyer Assessment-upper extremity (FMA-UE), Stroke Impact Scale (SIS) for hand dexterity and function. Hand held dynamometer will be used for Grip Strength Test. Pre intervention assessment will be conducted for both groups. The effects of intervention will be measured at pretreatment ,3rd week and post intervention. Data analysis will be performed by using SPSS (Statistical Package for Social Sciences) 23 version.

Conditions

Hemiplegia and Hemiparesis

Keywords

Paresis, Mirror therapy, Motor skills, Stroke

Outcome Measures

Primary Outcomes (4)

• Action Research Arm Test (For Functional Limitation)

  The instrument contains 19 items grouped into 4 subtests; grasp, grip, pinch, and gross motor. Item performance is rated on a 4-point scale (0=unable; 1=partial; 2= abnormal; 3=normal) then item ratings are summed and reported out of 57 points with higher score indicating greater UE function.

  Changes from baseline Action Research Arm Test at 3rd week and after 6 weeks

• Fugl-Meyer Assessment. (For Upper extremity function)

  The Fugl-Meyer Assessment is the gold standard to assess motor function of post-stroke hemiparesis. The FMA-UE consists of 30 items assessing motor function and 3 items assessing reflex function. The scores most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal" (total score range, 0-66).Higher the score more is the independence.

  Changes from baseline Fugl-Meyer Assessment at 3rd week and after 6 weeks

• Hand-held dynamometer. (For Upper Limb strength assessment)

  This instrument is scored using force produced in kilograms (0-90) or pounds (0-200). The subject is seated with back, pelvis and knees as close to 90 degrees as possible, shoulder is adducted and neutrally rotated, elbow flexed to 90 degrees, and forearm neutral and wrist held between 0-15 degrees of ulnar deviation. Maximum grip is the mean of 3 trails.

  Changes from baseline Fugl-Meyer Assessment at 3rd week and after 6 weeks

• Stroke Impact Scale (For hand function)

  The Stroke Impact Scale (SIS) is a stroke-specific, self-report, health status measure. It contains 59 items and assesses 8 domains: Strength - 4 items, Hand function - 5 items, ADL/IADL - 10 items, Mobility - 9 items, Communication - 7 items, Emotion - 9 items, Memory and thinking - 7 items, Participation/Role function - 8 items. For each item individual is asked to rate the level of difficulty in past two weeks using the scale;1= extremely difficult, 2= very difficult, 3= somewhat difficult, 4= a little difficult, 5= not difficult at all. On a scale of 0 to 100, with 100 representing full recovery and 0 representing no recovery.

  Changes from baseline Fugl-Meyer Assessment at 3rd week and after 6 weeks

Study Arms (2)

Group A: Cross education

EXPERIMENTAL

For strength training resistance exercises with a load of 60% of one repetition maximum will be performed targeting the muscles involved in upper limb function. It includes exercises like shoulder presses, wrist curls, elbow flexion, and triceps extensions. Among the functional movements that are the focus of motor skill training activities for non-paretic limbs are reaching, gripping, and object manipulation. Patient will be encouraged to mentally visualize themselves performing movements and tasks with the affected limb, while actively engaging the non-paretic limb. Strength will be measured using the grip strength test/ hand held dynamometer. Patients will undergo 45-minute session per day, 3 days per week for 6 weeks.

Other: Cross education

Group B: Mirror Therapy

EXPERIMENTAL

Participants will be asked to sit in front of a table of appropriate height with their arms resting on the table and a mirror (35 cm × 35 cm) placed between the patient's arms. The non-affected arm will be placed in front of the mirror and the affected arm will be placed and obscured. Patient will engage in specific exercises or movements using the affected limb while observing the mirror reflection. The movements will consist of forearm rotation, elbow, wrist, and finger flexion and extension movements, and hand grasping. Appropriate movement tasks will be selected according to the function of the affected upper limb. This exercise will be performed 45 minutes per day, 3 times per week for 6 weeks.

Other: Mirror Therapy

Interventions

Cross education OTHER

For strength training resistance exercises with a load of 60% of one repetition maximum will be performed targeting the muscle involved in upper limb function. Strength will be measured using the grip strength test/hand held dynamometer. Patients will undergo 45 minute session per day, 3 days per week for 6 weeks.

Group A: Cross education

Mirror Therapy OTHER

Participants will be asked to sit in front of a table of appropriate height with their arms resting on the table and a mirror (35 cm × 35 cm) placed between the patient's arms. The non-affected arm will be placed in front of the mirror and the affected arm will be placed and obscured. Appropriate movement tasks will be selected according to the function of the affected upper limb. This exercise will be performed 45 minutes per day, 3 times per week for 6 weeks

Group B: Mirror Therapy

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range between 45-65 years.
• Both male and female genders.
• Clinically diagnosed of stroke referred by Neuro physician.
• Patients in the subacute stage, duration of 3 to 6 months from onset.
• Patients with anterior cerebral artery (ACA) and middle cerebral artery (MCA) involvement with the affected side being the dominant side.
• Patients with Mini-Mental State Examination (MMSE) score more than 16.
• According to Modified Ashworth Scale, patients in range of 1 and 1+ (Flexor carpal radialis muscle,Flexor carpal ulnaris muscle, Flexor digitorum profundus muscle, Flexor digitorum superficialis muscle, Flexor pollicis longus muscle, Palmaris longus muscle) will be included .
• Hemiparesis or hemiplegic due to Ischemic stroke

You may not qualify if:

• Patients with Alzheimer disease, Parkinson's disease, Multiple sclerosis and Brain tumors .
• Those with severe cognitive impairment , those who were unable to provide informed consent. Patients having acute pericarditis, lumbar puncture within 7 days, Major surgery or major trauma within 14 days.
• Patient with recurrent stroke.
• With unilateral neglect or apraxia

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Tehreem Mukhtar

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Hemiplegia; Paresis; Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Kianat Rashid, MSPT-NM

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tehreem Mukhtar, PhD*

CONTACT

+923134715275; tehreem.mukhtar@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 29, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 15, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)