NCT06292403

Brief Summary

The aim of this study is to find the effects of strength training with or without mirror therapy of non-paralytic upper limb for functional activities and in lower limb for gait pattern, balance and stability, and ADLs of paralytic side in patients with acute and sub-acute stroke. A randomized controlled trial that will include total 44 participants .The control group will undergo usual rehabilitation training along with strength training. The trial group will undergo strength training and mirror therapy of NHS on the basis of usual rehabilitation training. For the control group, training time will be 30 minutes, once a day, 3 days a week for 8 weeks. IN trial group, training time will be 30 minutes therapy, once a day, 3 days a week for 8 weeks. were allowed to rest for 3-5 min during each training. Data collected will be analyzed through SPSS 25.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

March 10, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

November 24, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

Hemiplegic strokestrength training AND strokeMirror therapy AND strokestroke rehabilitationstrength training and mirror therapy

Outcome Measures

Primary Outcomes (3)

  • Modified Barthel Index

    MBI is a five-level rating scale, including evaluation of bathing, grooming, feeding, dressing, bowels, bladder, toilet, stairs, chair/bed transfers, and walking. Higher scores represent higher degree of ADL independence. MBI was an efficient, reliable, and valid assessment of ADL for stroke patients.

    8 weeks

  • Dynamic Gait Index

    Dynamic Gait Index (DGI) is a performance-based tool that quantifies the dynamic balance instability developed by Shumway-Cook and Woollacott, evaluates the ability of the individual to modify gait in response to changing functions during walking.

    8 weeks

  • Berg Balance Scale

    Consists of 14 tasks and total score of 56.score of 0-20 indicates severe fall risk, 20-45 includes moderate risk of fall and 45-60 illustrates thr functional balances state.

    8 weks

Study Arms (2)

Strength Training

ACTIVE COMPARATOR

Non-hemiplegic lower limb stepping forward training Non-hemiplegic upper limb pulling elastic belt in standing position repeatedly Hemiplegic lower limb stepped over an obstacle or climbed a platform The patients will stretch their arms to touch distant objects in a standing position repeatedly.

Other: Strength Training

Mirror Therapy and strength Training Group

EXPERIMENTAL

Participants in the (trial group) mirror and strength training group observed the reflection of the exercising arm and leg in the mirror. Participants in the (control group) strength training only group will exercise without a mirror entirely.

Other: Strength TrainingOther: Mirror therapy

Interventions

training time will be 30 minutes therapy, once a day, 3 days a week for 8 weeks. were allowed to rest for 3-5 min during each training.

Mirror Therapy and strength Training GroupStrength Training

Participants in the (trial group) mirror and strength training group observed the reflection of the exercising arm and leg in the mirror. Participants in the (control group) strength training only group will exercise without a mirror entirely.

Mirror Therapy and strength Training Group

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Girls aged 17-24 years with regular --Menstrual cycle
  • Unmarried girls

You may not qualify if:

  • Athletes
  • Married women
  • Girls who were regularly exercising
  • Having any pelvic pathology
  • Abnormal menstrual cycle.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatima Hospital

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Stroke

Interventions

Resistance TrainingMirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sara Aabroo Aabroo, Nmpt

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Aabroo Aabroo, Ms NMPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups 1. Strength training only group 2. strength training and mirror therapy group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2023

First Posted

March 5, 2024

Study Start

March 10, 2024

Primary Completion

December 30, 2024

Study Completion

January 1, 2025

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations