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StrokeNCT06807814

COMPERATIVE EFFECTS of CONSTRAINT- INDUCED MOVEMENT THERAPY and MIRROR THERAPY on FUNCTIONAL AMBULATION and QUALITY of LIFE in CHRONIC STROKE PATIENTS

A study testing Constraint-Induced Movement Therapy (CIMT)) and Mirror Therapy in people with Stroke and Stroke Rehabilitation, run by University of Lahore at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Stroke is a global health issue as this happens when the blood flow to the brain is disrupted or reduced, depriving the brain tissue of sugar and oxygen. This interruption affects the brain cells hence leading to the loss of a cell Various physical, cognitive and emotional losses are experienced. Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Stroke, Stroke Rehabilitation, Mirror Therapy
What is being tested?
Constraint-Induced Movement Therapy (CIMT)) and Mirror Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 sitePakistan
Study dates
26 Jan 2024to 20 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants having age between 21 and 70 years old were recruited (e Silva et al., 2017).
  • Both genders included (e Silva et al., 2017).
  • Diagnosed with post chronic hemiplegia ischemic stroke (≥6 months) affecting one side of the body(Danlami \& Abdullahi, 2017; Mansfield et al., 2018).
  • Participants having ability to follow verbal and visual instructions(Danlami \& Abdullahi, 2017).
  • Participants having no significant cognitive impairment (Minimental state examination score ≥ 17(Danlami \& Abdullahi, 2017).
  • Participants having low risk of fall (Tinetti gait and balance score ≥20)(Danlami \& Abdullahi, 2017).

Who cannot join

  • History of other neurological conditions affecting mobility. (Mansfield et al., 2018).
  • Unstable fracture or other orthopedic conditions affecting gait such as OA, fracture and arthritis (Page et al., 2007).
  • --Severe cognitive impairment.
  • Participants with severe hemiparesis who are unable to reproduce movements accurately with the affected limb, as this may hinder active participation in the therapy(Danlami \& Abdullahi, 2017; Ezendam et al., 2009).
  • Individuals with physical limitations that prevent them from positioning themselves adequately to view their affected limb in the mirror during therapy sessions, as this could compromise the effectiveness of mirror therapy(Danlami \& Abdullahi, 2017).

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • University of Lahore Teaching Hospital

    Lahore, Punjab Province, 5654590

Other trials in Pakistan

About this study

Stroke is a global health issue as this happens when the blood flow to the brain is disrupted or reduced, depriving the brain tissue of sugar and oxygen. This interruption affects the brain cells hence leading to the loss of a cell Various physical, cognitive and emotional losses are experienced. Cerebrovascular accident or simply stroke, is the fifth cause of mortality and one of the most common causes of disability in the United States of America (Campbell et al., 2019). There are two main types of stroke: ischemic and hemorrhagic. An ischemic stroke is characterized by an occlusion of a cerebral artery by an embolus or thrombus while hemorrhagic stroke results from a hemorrhage in the brain due to rupture of a blood vessel. A TIA or so-called mini stroke occurs when the clot is not severe enough to result in lasting symptoms (Feigin et al., 2022; Strilciuc et al., 2023).

Strokes substantially affect an individual mobility and overall quality of life, although few comparative studies comparing CIMT and MT exist in the literature. This research therefore seeks to systematically compare the effects of these two interventions on functional ambulation and quality of life of chronic stroke patients. Hereby, the research compares structured, task specific CIMT with the less structured, more general approach of MT in order to offer clinicians empirically founded recommendations on what course of action might prove effective for patients. This study also provides new insights to the field given that it not only describes the potential of CIMT within outpatient physiotherapy treatment but also provides an overview of the long-term effects for patients with stroke. These outcomes of this study will be useful in developing rehabilitative research, improving clinical practice protocols, and thereby improve the lifestyles of people living with chronic stroke.

Read the detailed description

To compare the effects of MT and CIMT on functional ambulation and quality of life in chronic stroke patients.

Study Design: This was a randomized controlled trial with two parallel groups:

  1. Group A (Constraint-Induced Movement Therapy (CIMT)): A well-defined and structured rehabilitation program that restricts the use of the unaffected limb to promote the functional recovery of the affected limb in chronic stroke patients(Franck et al., 2019).
  2. Group B (Mirror Therapy):

A specific intervention that uses a mirror to create a visual illusion of the affected limb, with the goal of improving motor function and quality of life in chronic stroke patients

  • Screening: Patients was screened to meet inclusion criteria. The consent form was taken from patients then patients was randomly allocated into two groups (33 in each group).
  • Randomization: Patients fulfilling the inclusion criteria will be randomly divided into experimental and control groups using the computer software.
  • Blinding: The study will be single blinded. The assessor, who has 5 years of experience in both clinical practice and research, will be unaware of the treatment given to both groups and will assess the participants objectively.
  • Allocation: Allocation of the participants will be concealed, and envelope concealment method will be used for it.
  • Outcome Measures:
  • Functional Ambulation Categories (FAC)
  • Tinetti gait and balance score (POMA)
  • Short Form Health Survey (SF-12) Ethical Considerations: This study has received ethical approval from the Institutional Review Board (IRB). Informed consent was obtained from all participants.

Data Analysis: Statistical software was used to analyze the data, with appropriate tests employed based on data normality to compare outcomes between groups.

Being tested
Constraint-Induced Movement Therapy (CIMT)), Mirror Therapy
Keywords
CONSTRAINT INDUCED MOVEMENT THERPHY, Stroke Rehabilitation, Mirror Therapy, Functional Ambulation, Quality Of Life
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Constraint-Induced Movement Therapy (CIMT))Combination product

    A well-defined and structured rehabilitation program that restricts the use of the unaffected limb to promote the functional recovery of the affected limb in chronic stroke patients(Franck et al., 2019). Sit-to-stand transitions, Indoor overground walking (forward, backward, and sideways), Weight-bearing movements in different directions: Stepping over obstacles and climbing stairs, Ideally, specific tasks to involve the paretic limb according to the activity of stroke survivors. This task was repeated ten times as part of the therapy sessions. Dynamic strengthening exercises like squats and lunges are integrated, progressively increasing intensity as patients gain confidence and strength. Balance and core stability exercises, including single-leg stances and seated weight shifts on therapy balls, address postural control and stability.(Cabanas-Valdés \& Boix-Sala, 2021)

  • Mirror TherapyBehavioural

    A specific intervention that uses a mirror to create a visual illusion of the affected limb, with the goal of improving motor function and quality of life in chronic stroke patients. The MT protocol included 10 minutes of warm-up, 1 hour of mirror box training, and 50 minutes of functional task practice. The warm-up activities included stretching and passive range of motion exercises. During the mirror box training, a mirror box that reflected the image of the unaffected arm was placed in the participant's midsagittal plane. Participants were required to symmetrically move both hands as simultaneously as possible while watching the reflection of the unaffected arm in the mirror as if it were the affected one. To ensure that the participants focused on the reflection, the unaffected arm was placed in the mirror box, and vision of the affected arm was occluded by a vertical board placed beside the mirror box. The activities consisted of transitive (eg, gross motor tasks, such as reaching

Study groups in NCT06807814
Study groupRoleWhat they receive
Constraint-Induced Movement Therapy (CIMT)ExperimentalA well-defined and structured rehabilitation program that restricts the use of the unaffected limb to promote the functional recovery of the affected limb in chronic stroke patients.
Receives: Combination Product: Constraint-Induced Movement Therapy (CIMT))
Mirror TherapyExperimentalA specific intervention that uses a mirror to create a visual illusion of the affected limb, with the goal of improving motor function and quality of life in chronic stroke patients.
Receives: Behavioral: Mirror Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Ambulation Categories (FAC)

    Functional Ambulation Categories (FAC) is a 6-point functional walking test that provides the quantitative measurement of ambulation ability, which means how much human assistance the patient needs while walking, even with personal dual assistive device

    Measured: 8 weeks (baseline, fourth week and then at the end of the 8 week)

  2. Tinetti gait and balance score (POMA)

    Tinetti Balance and Gait Assessment Performance Oriented Mobility Assessment (POMA) is a tool designed to assess the balance and gait status of a person with special reference to the potential for falling (Miodonska et al., 2018).

    . Scores are interpreted to reflect fall risk: Pollock et al. categories the serve self-tested mobility at low risk for participants scoring 25-28 points, moderate risk if scoring 19-24 points and high risk if scoring below 19 points on the scale. Also, patients with a score of below 26 are normally classified as high risk of falling.

    Measured: 8 weeks (baseline, fourth week and then at the end of the 8 week)

  3. Short Form Health Survey (SF-12)

    The SF-12 scoring system generates two summary measures: th.e fact that the patients' disabilities are measured by the Physical Component Summary (PCS) and the Mental Component Summary (MCS). These scores are normalized based on a mean of 50 and standard deviation of 10 to obatain meaningful numerical values. Higher numbers represent better health related quality and those utilities with values above 50 represent superior health while below 50 represent inferior health. (Sampogna et al., 2019).

    Measured: 8 weeks (baseline, fourth week and then at the end of the 8 week)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2025
  2. Study start26 Jan 2024
  3. Primary completion12 Nov 2024
  4. Study completion20 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1. Group A (Constraint-Induced Movement Therapy (CIMT 2. Group B (Mirror Therapy):
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06807814
Sponsor's protocol ID
REC-UOL-/246/08/24
Status last verified
Jan 2025
First submitted
29 Jan 2025
Last updated
4 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ezendam D, Bongers RM, Jannink MJ. Systematic review of the effectiveness of mirror therapy in upper extremity function. Disabil Rehabil. 2009;31(26):2135-49. doi: 10.3109/09638280902887768.

    PubMed 19903124
  • Iliyasu Z, Galadanci HS, Danlami KM, Salihu HM, Aliyu MH. Correlates of Postpartum Sexual Activity and Contraceptive Use in Kano, Northern Nigeria. Afr J Reprod Health. 2018 Mar;22(1):103-112. doi: 10.29063/ajrh2018/v22i1.10.

    PubMed 29777647
  • Feigin VL, Brainin M, Norrving B, Martins S, Sacco RL, Hacke W, Fisher M, Pandian J, Lindsay P. World Stroke Organization (WSO): Global Stroke Fact Sheet 2022. Int J Stroke. 2022 Jan;17(1):18-29. doi: 10.1177/17474930211065917.

    PubMed 34986727
  • Campbell BCV, De Silva DA, Macleod MR, Coutts SB, Schwamm LH, Davis SM, Donnan GA. Ischaemic stroke. Nat Rev Dis Primers. 2019 Oct 10;5(1):70. doi: 10.1038/s41572-019-0118-8.

    PubMed 31601801
  • Rubiera M, Aires A, Antonenko K, Lemeret S, Nolte CH, Putaala J, Schnabel RB, Tuladhar AM, Werring DJ, Zeraatkar D, Paciaroni M. European Stroke Organisation (ESO) guideline on screening for subclinical atrial fibrillation after stroke or transient ischaemic attack of undetermined origin. Eur Stroke J. 2022 Sep;7(3):VI. doi: 10.1177/23969873221099478. Epub 2022 Jun 3.

    PubMed 36082257

Questions about this trial

What is this clinical trial studying?

A study testing Constraint-Induced Movement Therapy (CIMT)) and Mirror Therapy in people with Stroke and Stroke Rehabilitation, run by University of Lahore at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Ambulation Categories (FAC) (time frame: 8 weeks (baseline, fourth week and then at the end of the 8 week)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06807814, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.

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