NCT06698380

Brief Summary

The study aimed to determine the effect of mirror therapy versus conventional physical therapy treatment in improving upper extremity impairments and motor function among chronic hemiplegic subjects. Research Objectives:

  1. 1.To discover the effectiveness of conventional physical therapy treatment on improving upper limb motor function among chronic hemiplegic subjects.
  2. 2.To find out the effect of mirror therapy along with conventional physical therapy treatment on improving upper limb motor function among chronic hemiplegic subjects.
  3. 3.To find out the effectiveness of mirror therapy combined with conventional physical therapy treatment versus conventional physical therapy treatment alone on improving upper extremity motor function among chronic hemiplegic subjects.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

November 18, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

November 18, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

November 18, 2024

Last Update Submit

November 18, 2024

Conditions

Keywords

storkeHemiplegiamirror therapyupper extremitymotor function

Outcome Measures

Primary Outcomes (2)

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

    The most widely applied method in post-stroke rehabilitation to estimate gross motor impairment is the FMA. It pursues the concept of stages of recovery for stroke patients, which developed with Twitchell and Brunnstrom. It gauges the capacity to manage isolated joints, which are impeded by synergy, and the strength of muscle, with an assumed order of difficulty. The components of the assessment are five including: joint range of motion (ROM), balance, sensory function, motion of the joint, and joint discomfort. FMA-UE is split into whole, proximal, and distal components and these subtests investigate the movement of body parts independently, with the authors recommending that every part of UE heal alone. It is used in the clinical field and in research to detect disease progress, prescribe exercise recovery, and prepare and evaluate medicine. FMA has as well demonstrated excellent inter- and intra-rater reliability, also the feasibility of construction.

    week 0 and week 6

  • Wolf Motor Function Test (WMFT)

    This examination tool was designed to estimate and evaluate the exercise capacity of individuals who suffer from mild to acute upper extremity motion impairments in laboratory and clinical settings. It is an improvement of a previous examination tool utilized in high-functioning patients, but difficult to perform in patients with minimal capacity of movement in the hands and fingers. WMFT has proven its significance in describing motion status in terms of severity and upper extremity motion impairments in a cohort of chronic individuals who suffer from stroke and traumatic brain injury in high-functioning individuals. The inter-test and inter-rater reliability, internal consistency of tests, and stability for schedule measures of performance and functional ability were high, varying from 0.88 to 0.98, with most estimates' relative from 0.95

    week 0 and week 6

Study Arms (2)

Control

ACTIVE COMPARATOR

The participants of control participants received conventional Physical Therapy (CPT) based on their routine physical therapy neurological evaluation. The CPT was individualized based on the needs of the subjects. It included: normalization of muscle tone, strengthening of weak muscles, lengthening of tight muscles, training for transfers like supine to sit, sit to stand, balance training, and gait training. The upper extremity training for ADLs also were incorporated using mobilization, reaching, grasping and dexterity movements

Other: Conventional Physical Therapy

Experimental

EXPERIMENTAL

The experimental group received combination therapy that is MT combined with CPT treatment. The subjects were asked to be seated on a comfortable chair with feet and back supported and the upper extremity was on a tabletop surface of two-by-two- meter size. A mirror was positioned in front of the subjects to shield the involved upper extremity, reflecting the image of the uninvolved side. The involved upper extremity was placed in a relaxed posture beside the mirror, mirroring the same posture on the uninvolved side to enhance illusional movements. The MT for the experimental group included reaching, grasping, and dexterity movements of the unaffected upper limb, followed by imitation on the involved side. Subjects performed five activities: finger flexion and extension, finger opposition, counting with fingers, wrist flexion and extension, and forearm supination and pronation. Each activity was done 10 times, with mirror therapy lasting 15 minutes and 30 minutes / 6 weeks.

Other: Mirror Therapy

Interventions

The subjects of the control group received the CPT based on their routine physical therapy neurological evaluation. The CPT was individualized based on the needs of the subjects. It included: normalization of muscle tone, strengthening of weak muscles, lengthening of tight muscles, training for transfers like supine to sit, sit to stand, balance training, and gait training. The upper extremity training for ADLs also were incorporated using mobilization, reaching, grasping and dexterity movements

Control

A mirror was positioned in front of the subjects to shield the involved upper extremity, reflecting the image of the uninvolved side. The involved upper extremity was placed in a relaxed posture beside the mirror, mirroring the same posture on the uninvolved side to enhance illusional movements. The MT for the experimental group included reaching, grasping, and dexterity movements of the unaffected upper limb, followed by imitation on the involved side. Subjects performed five activities: finger flexion and extension, finger opposition, counting with fingers, wrist flexion and extension, and forearm supination and pronation. Each activity was done 10 times, with mirror therapy lasting 15 minutes followed by 30 minutes of CPT treatment. Each session lasted 45 minutes, held three times per week over six weeks.

Experimental

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Duration of stroke more than six months
  • Subjects of chronic stroke with left or right hemiplegia.
  • Genders of male and female with age ranging between forty-five to sixty-five years.
  • MMSE scores greater than 23 out of 30.
  • Scored one or one plus on MAS on all muscles of the affected upper limb.
  • Have normal visual perception.
  • Able to follow oral commands.

You may not qualify if:

  • Unable to follow visual and oral commands.
  • Unilateral neglect.
  • Cognitive impairments (MMSE scores less than 24 out of 30), or language deficits.
  • Any other neurological disorders and recent surgeries.
  • Previous exposure to MT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud Medical City

Riyadh, Riyadh Region, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

StrokeHemiplegia

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Central Study Contacts

Mohammed Mansour Al Shehri, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 18, 2024

First Posted

November 21, 2024

Study Start

November 18, 2024

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

November 21, 2024

Record last verified: 2024-11

Locations