NCT04707755

Brief Summary

To determine the effects of motor imagery technique on lower limb function among stroke patient. To determine the effects of motor imagery technique on lower limb spasticity among stroke patients. To determine the effects of motor imagery technique on gait among stroke patients. To determine the effects of motor imagery technique on quality of life among stroke patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

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

August 30, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

January 12, 2021

Last Update Submit

January 12, 2021

Conditions

Keywords

GaitLower Limb functionMotor imagery

Outcome Measures

Primary Outcomes (5)

  • Lower Extremity Function scale

    It is 20 items questionnaire, measure the lower extremity function scoring from 1 to 4 for each items, in which minimum score is 0 and maximum score of 80 shows the maximum functional status. It has a valid and reliable tool to measure the lower extremity functional status.

    8 weeks

  • Dynamic Gait Index

    It assess gait, balance and fall risk, with 24 is the maximum score, in which 19 or less have been related to increase incidence of falls. It has high reliability and validity in the stroke population.

    8 weeks

  • Time Up and Go test

    It assess a person's mobility and requires both static and dynamic balance. Score of less than 10 seconds indicate freely mobile,\<20 seconds mostly independent, 20-29 seconds variable mobility, \>30 seconds Impaired mobility. It is reliable, valid, and easy to administer clinical tool in stroke patients.

    8 weeks

  • Stroke Specific Quality of Life Scale

    It is a self-report questionnaire, measure the quality of life in stroke patients consisting of 49 items in the 12 domains. Scoring from 1 to 5 , in which 1 shows strongly agreement and 5 shows strongly disagreement. It is a reliable and valid tool for measuring the quality of life for stroke patients.

    8 Weeks

  • Modified Ashworth scale

    It measures the spasticity, ranging from 0 means normal tone to 4 shows increased tone to such extent where passive movement is not possible. It has good intra-rater reliability and validity in stroke patients .

    8 Weeks

Study Arms (2)

Motor imagery technique

EXPERIMENTAL

Motor Imagery technique Plus Conventional Physical therapy

Other: Motor imagery technique

Conventional Physical therapy

ACTIVE COMPARATOR

passive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs.

Other: Conventional Physical Therapy

Interventions

The patient will sit on chair in a quiet room. The patients will be observing motor performance in video, motor performance video will consist of (1) knee flexion and extension movement, (2) sitting to standing movement, (3) stepping movement, (4) walking, (5) climbing and descending stairs. Addition to motor imagery, the patients will be provided the passive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs.

Motor imagery technique

It includes passive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs.

Conventional Physical therapy

Eligibility Criteria

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

You may qualify if:

  • Adult without ADHD by Adult ADHD Self-Report Scale score.
  • History of no more than one stroke.
  • Lower limb muscles spasticity with the grade 1+ or 2 on modified Ashworth in scale.
  • Mini-mental status score more than 25.
  • Patients who are less than 6 months post-stroke.
  • Modified Rankin scale score is 4.

You may not qualify if:

  • Lesion of frontal, parietal and basal ganglia
  • Excessive spasticity that is score of\>3 on modified Ashworth spasticity scale.
  • Any musculoskeletal disorder impeding lower limb function.
  • Participating in any experimental rehabilitation or drug studies.
  • Bed ridden patient.
  • Subjects psychiatric disorder or dementia.
  • Any neglect of space on the affected side, or any other neurological disease or auditory or visual.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bibi Zahida Memorial Teaching Hospital

Peshawar, KPK, 251900, Pakistan

Location

Related Publications (3)

  • Gul I, Malik MS, Halim A, Rauf S. POST STROKE DEPRESSION: EXPERIENCE AT A TERTIARY CARE HOSPITAL OF PAKISTAN. Pakistan Armed Forces Medical Journal. 2019 Aug 27;69(4):779-83.

    BACKGROUND
  • Paravlic AH, Pisot R, Marusic U. Specific and general adaptations following motor imagery practice focused on muscle strength in total knee arthroplasty rehabilitation: A randomized controlled trial. PLoS One. 2019 Aug 14;14(8):e0221089. doi: 10.1371/journal.pone.0221089. eCollection 2019.

    PMID: 31412056BACKGROUND
  • Pedersen SG, Heiberg GA, Nielsen JF, Friborg O, Stabel HH, Anke A, Arntzen C. Validity, reliability and Norwegian adaptation of the Stroke-Specific Quality of Life (SS-QOL) scale. SAGE Open Med. 2018 Jan 8;6:2050312117752031. doi: 10.1177/2050312117752031. eCollection 2018.

    PMID: 29344360BACKGROUND

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mirza Obaid Baig, MSPT(NMR)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 13, 2021

Study Start

August 30, 2020

Primary Completion

November 28, 2020

Study Completion

November 30, 2020

Last Updated

January 13, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations