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Comparison of Mirror Therapy and Modified Constrain Induced Movement Therapy on Risk of Fall, Balance and Gait in Stroke

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05985603
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
10.5
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There will be a difference between modified constraint induced movement therapy and Mirror Therapy on lower limb for risk of fall, balance and gait in stroke patients.

Condition or Disease Intervention/Treatment Phase
  • Other: CIMT Group
  • Other: Mirror Therapy group
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparison of Mirror Therapy and Modified Constrain Induced Movement Therapy on Risk of Fall, Balance and Gait in Stroke
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jan 30, 2024
Anticipated Study Completion Date :
Feb 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: CIMT Group

In this group of patients CIMT technique will be used for treatment

Other: CIMT Group
In this group of patients CIMT technique will be used for treatment
Experimental: Mirror Therapy Group

patient will perform movements in semi-reclined and sitting positions with the mirror placed between the two lower extremities.

Other: Mirror Therapy group
patient will perform movements in semi-reclined and sitting positions with the mirror placed between the two lower extremities.

Outcome Measures

Primary Outcome Measures

  1. NIH Stroke Scale - NIHSS [2,4,8 week]

    It comprises of 15 items with each having responses scored on a 0-4 points scale. The overall score ranges from 0-42 points with higher scores specifying pronounced neurological deficits

  2. Mini-mental state examination [2,4,8 week]

    Cognitive status by the mini-mental state examination (mmse)Mini-Mental State Examination (MMSE) is a tool that can quickly diagnose if a person suffers from mild cognitive impairment (MCI) through answering questions in different cognitive domains. The MMSE demonstrates moderately high levels of reliability. It has been reported to be internally consistent

  3. POMA [2,4,8 week]

    After interventions POMA for assessing risk of fall will be used. The POMA is used to examine balance and mobility in the elderly (Tinetti 1986). This examination tool consists of the balance subscale (9 items, 16 points) and gait subscale (8 items, 12 points), totaling 28 points.

  4. Berg balance scale [2,4,8 week]

    A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 0-56. Score of 41-56 = low fall risk, 21-40 = medium fall risk, 0-20 = high fall risk.

  5. 10 Meter walk test / 10mwt [2,4,8 week]

    Calculating Gait Speed - total distance/time. For example: if you did a 10-meter gait speed test and it took you 7 seconds, the equation would like: 10 meters / 7 seconds = 1.4 meters per second. The 10MWT intra-rater and inter-rater reliability were good (ICC between 0.76 until 0.9) and excellent (ICC > 0.9), respectively. The minimal detectable change for intra-rater reliability was 0.188 m/s.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • A Hemiplegia due to unilateral stroke

  • Sub-acute and chronic stroke

  • Stroke survivors between 21 and 70 years old will be recruited

  • Both genders

  • NIH Stroke scale below 20

  • Mini-Mental State Examination above 24

  • Function in Sitting Test (FIST) above 42/56

Exclusion Criteria:

  • Patients with depression who will be unable to cooperate during treatment

  • Patients who cannot perform the active movement of limb due to prestroke muscoskeletal problems

  • Cardiopulmonary diseases which could hinder their ability to participate in rehabilitation

  • Spasticity of Modified Ashworth Scale (MAS) II or higher

  • Patients with Any neuron disease and Patients with lower-limb impairment caused by other neurological diseases or inability to comply with study protocol will be excluded.

  • Visual and auditory abnormalities

Contacts and Locations

Locations

Site City State Country Postal Code
1 Helping Hand Institute Of rehabilitation sciences Mansehra KPK Pakistan 21300

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Ayesha Bashir, MS, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05985603
Other Study ID Numbers:
  • REC/00234 Bakhtawar Tariq
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
CIMT
Mirror Therapy
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Aug 14, 2023