NCT06308211

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

March 4, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

Mirror therapyMotor relearning ProgrammestrokeMotor Imagery

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

GROUP A (MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPY)

EXPERIMENTAL

Group A will receive treatment session of 60 minutes including motor imagery for 20 minutes and mirror therapy for 20 minutes along with routine physical therapy of 20 minutes for 5 days per week for 12 weeks.In motor imagery subjects will watch the video and will be asked to close the eyes to focus and imagine how they are doing task they had previously observed 10 times and instructed to carry out the task in verbal commands given whenever necessary. In mirror therapy,The unaffected limb will be placed in front of the mirror and patient will try to make the identical motions with the paretic limb while moving the non-paretic limb during the session 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).

Other: MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPY

GROUP B (MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPY)

EXPERIMENTAL

GROUP B will receive treatment session of 60 minutes including motor relearning program of 40 minutes duration along with routine physical therapy of 20 minutes as explained in group A protocol. Treatment session will be given 5 days per week for 12 weeks. Motor relearning consists of five components including analysis of task, practice of missing components, practice of task and transference of training.

Other: MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPY

Interventions

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).

Also known as: Rehabilitation
GROUP A (MOTOR IMAGERY+MIRROR THERAPY+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).

Also known as: Rehabilitation
GROUP B (MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPY)

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke patient of both gender.
  • Stroke patient of age 40-65 year .
  • Patient diagnosis of cerebral ischemic stroke .
  • Patients who had suffered a stroke with hemiplegia, were subacute at least 3 months to 5 months since the onset.
  • Ability to walk with minimal assistance (functional ambulation category 1 to 3.
  • Patient with score \> 25 on mini-mental status examination.

You may not qualify if:

  • Patients who presented with hemiplegic neglect or apraxia
  • Patients with history of global or receptive aphasia
  • Patients with history of psychological or emotional problems
  • Patients with history of decompensated cardiovascular/ respiratory/ digestive/ renal disorders, biologic inflammatory syndrome, neoplastic disorders, neurogenic bladder or skin disorders (bedsores).
  • Patients with history of artificial joints

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhammad Kashif

Lahore, Punjab Province, 54660, Pakistan

Location

MeSH Terms

Conditions

Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Muhammad Kashif, PhD

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient would be allocated.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 13, 2024

Study Start

February 25, 2024

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations