Comparative Effects of Motor Imagery and Mirror Therapy Versus Motor Relearning Program in Subacute Stroke Patients

Stroke Clinical Trial

Official title:

Comparative Effects of Motor Imagery and Mirror Therapy Versus Motor Relearning Program on Balance, Motor Function and Activities of Daily Living in Subacute Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06308211
• Other study ID #: REC/RCR&AHS/23/0289
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2024
• Est. completion date: May 15, 2024

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: Muhammad Kashif, PhD-PT
• Phone: 03333125303
• Email: kashif.shaffi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Use of motor imagery, mirror therapy and motor relearning program in rehabilitation of people with stroke is on rise and these are unique and emerging techniques. Motor imagery is a mental rehearsal through visualization while mirror therapy creates a reflection of non-effected limb by using a mirror. Moreover, motor relearning is task-oriented approach, benefacial for balance and motor funCtion in patients with stroke that emphasizes on relearning.The aim of the study is to determine the comparative effects of motor imagery and mirror therapy versus motor relearning program in addition to routine physical therapy on balance, motor function and activities of daily living in subacute stroke patients.

Description:

This randomized clinical trial will be conducted at medical centre Fifty stroke patients will be included using convenience sampling technique. The participants in the study will be randomly allocated in to two groups . Twenty five participants will be included in both Groups A d B. Group A (motor imagery and mirror therapy) will receive 60 minutes treatment session that consists of 20 minutes motor imagery, 20 minutes mirror therapy along with 20 minutes routine physical therapy and Group B (motor relearning program) will receive treatment session of 60 minutes including motor relearning program of 40 minutes duration along with routine physical therapy of 20 minutes. Both groups will undergo 60 minutes session for 5 days per week for 12 weeks. Berg balance scale will be used to assess balance, Fugl-meyer assessment to assess motor function and Functional independence measure for activities of daily living. Assessment will be carried out at baseline, 4th week, 8th week and at 12th week after the discontinuation of treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: May 15, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Stroke patient of both gender.

2. Stroke patient of age 40-65 year .

3. Patient diagnosis of cerebral ischemic stroke .

4. Patients who had suffered a stroke with hemiplegia, were subacute at least 3 months to 5 months since the onset.

5. Ability to walk with minimal assistance (functional ambulation category 1 to 3.

6. Patient with score > 25 on mini-mental status examination.

Exclusion Criteria:

1. Patients who presented with hemiplegic neglect or apraxia

2. Patients with history of global or receptive aphasia

3. Patients with history of psychological or emotional problems

4. Patients with history of decompensated cardiovascular/ respiratory/ digestive/ renal disorders, biologic inflammatory syndrome, neoplastic disorders, neurogenic bladder or skin disorders (bedsores).

5. Patients with history of artificial joints

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPY
Subjects will be instructed to watch the video provided and recorded by investigator.In next step participants will be asked to close the eyes to focus and then to imagine how they are doing task they had previously observed 10 times.Participants will be than instructed to carry out the task in verbal commands given whenever necessary.The unaffected limb will be placed in front of the mirror so that the reflected illusion of the limb would be hallucinated to represent the affected limb and routine physical therapy includes passive and active assisted range of motion for the upper and lower extremity including the shoulder, forearm, wrist, hip, knee and ankle will be given (10 - 15 repititions).
• MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPY
Motor relearning consists of five components including analysis of task, practice of missing components, practice of task and transference of training. Patient will be asked to practice task in both sitting and standing supine to side-lying to sitting looking up at ceiling (ensure that centre of body mass does not move back when head is tilted back) without moving one's feet, turning to gaze over each other's shoulders and scanning the surroundings for specific items, reaching motions in multiple directions while moving the head and trunk, scooting in bed, altering the base of support (standing with your feet together, in tandem, with one foot on a step, or on one leg) squatting to pick up an object and cross over stepping and routine physical therapy includes Passive and active assisted range of motion for the upper and lower extremity including the shoulder, forearm, wrist, hip, knee and ankle will be given (10 - 15 repititions).

Locations

Country	Name	City	State
Pakistan	Muhammad Kashif	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg balance scale (BBS)	The BBS is postural balance scale containing 14 items including standing and sitting unsupported, reaching forward, and placing the alternating foot on a stool. Administering the BBS takes approximately 15 min. Each of the 14 items are scored on a 5-level ordinal scale from 0 ("unable to perform or requiring help") to 4 ("normal performance"), thus providing a potential maximum score of 56 points	12th week
Primary	FUGL-MEYER ASSESMENT (FMA)	The Fugl-Meyer Assessment is a welldesigned, feasible and efficient clinical examination method that has been tested widely in the stroke population. A three-level ordinal scale (0, can perform no part of the test; 1, performs test partially; 2, performs test normally) is applied to each item. A total possible score for the lower extremity is 34. The higher the score, the better the performance.	12th week
Primary	FUNCTIONAL INDEPENDENCE MEASURE (FIM)	The Functional Independence Measure (FIM) is one of the most frequently used outcome measures in stroke rehabilitation trials. The five FIM items dealing with transfers and locomotion, including transfers to bed/chair/wheelchair, toileting, bathing, walking or wheelchair management and stairs, were used in this pilot study to evaluate the activities of daily living in the patients with stroke. Each item is rated on a seven-level scale, with 1 = total assistance and 7 (complete independence). By adding the points for each item in the transfers and locomotion, the possible total score ranges from 5 (lowest) to 35 (highest) level of independence; the higher the score, the better the independence. This scale has good reliability for the assessment of recovery of function in stroke patients.	12th week