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StrokeNCT05948384

Mirror Therapy Versus PNF on LE Function in Stroke

A study testing PNF in people with Stroke, run by Riphah International University 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

Many rehabilitation strategies are being implemented to treat stroke. Constraint-induced movement therapy and robotics are two potentially useful treatment options for rehabilitation. Range of motion exercises, PNF, mirror therapy is also used. Read more about this study

Who is it for?
Ages 40 to 60 years
Conditions the study is for
Stroke
What is being tested?
PNF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 sitePakistan
Study dates
24 Jul 2023to 19 Jan 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 40 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Both male and female
  • ACA stroke
  • Ischemic and hemorrhagic stroke
  • MMSE grade >24
  • Spasticity at modified Ashworth scale between 1 and 2
  • Modified Rankin scale 4

Who cannot join

  • Any orthopedic impairment of lower extremity like LLD, fractures, dislocations, amputations, deformity of joint
  • Any other neurological condition (multiple sclerosis, Parkinson disease, SCI)

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Women Institute of Rehabilitation Sciences

    Abbottābād, Khyber Pakhtunkhwa

Other trials in Pakistan

About this study

Official title: Comparison of Mirror Therapy and PNF on Lower Extremity Function in Chronic Stroke Patients.

Many rehabilitation strategies are being implemented to treat stroke. Constraint-induced movement therapy and robotics are two potentially useful treatment options for rehabilitation. Range of motion exercises, PNF, mirror therapy is also used. Fitness training, high-intensity treatment, and repetitive-task training are all promising strategies that might help improve elements of gait. Repeated task training may also help with transfer functions

Read the detailed description

PNF and mirror therapy has its effect on chronic stroke patients. Both mirror therapy and PNF work on the concept of neuroplasticity. Neuroplasticity is the ability of the nervous system to change its activity in response to intrinsic or extrinsic stimuli by reorganizing its structure, functions, or connections after injuries. Because of brain plasticity, neurorehabilitation has evolved, as evidenced by numerous physiotherapeutic approaches such as proprioceptive neuromuscular facilitation (PNF) and mirror treatment (MT). The reorganization also includes the expansion of cortical regions, which offer the neural foundation for the recovery or adaption of motor activity following injury.

As the literature supports the individual effects of both techniques in stroke population but as per author's access, there is no literature provide the comparison among both techniques i.e. PNF and mirror therapy in lower limb for chronic stroke patients on gait and functionality. Hence the author established the research question that is there any difference among these techniques in stroke population in terms of its effects and efficiency on gait and functionality. The study will provide an insight to the clinician about which technique has the superior/ better effects for the lower extremity functions in chronic stroke patients thus telling the effects two neurorehabilitation methods i.e. proprioceptive neuromuscular facilitation (PNF) and mirror therapy (MT).

Conditions
Stroke
Being tested
PNF
Medical subject headings
Stroke

What participants receive

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

  • PNFOther

    For the PNF intervention, we applied a lower extremity hip extension-abduction-internal rotation with knee extension pattern, together with the rhythmic initiation of a repeated stretch and a combination of isotonic techniques. By this we'll target rectus femoris, medial gastrocnemius, lateral gastrocnemius, biceps femoris and semitendinosus musculature of the patient. The session will be given in 2 sets of 5 repetitions with rest of 45 seconds

Study groups in NCT05948384
Study groupRoleWhat they receive
PNF GroupActive comparatorFor the PNF intervention, we applied a lower extremity hip extension-abduction-internal rotation with knee extension pattern, together with the rhythmic initiation of a repeated stretch and a combination of isotonic techniques. By this we'll target rectus femoris, medial gastrocnemius, lateral gastrocnemius, biceps femoris and semitendinosus musculature of the patient. The session will be given in 2 sets of 5 repetitions with rest of 45 seconds
Receives: Other: PNF
Mirror Therapy GroupOtherMirror treatment is a sort of motor imagery in which the patient exercises his unaffected limb while looking at himself in the mirror. It involves placing the affected limb behind a mirror. The mirror is positioned so the reflection of the opposing limb appears in place of the hidden limb. The patient then looks into the mirror on the side with unaffected limb and makes "mirror symmetric" movement. It will implemented for about 30 minutes with 2, 2 minutes rest in between. Patient will perform as many repetitions as they could of knee flexion \& extension, ankle dorsiflexion \& plantarflexion and functional tasks (rolling the foot over the roller, reaching would be accomplished by asking the patient to reach towards objects through his leg e.g. touching the feet to a certain object at a particular height and distance, cycling) depending on patient's ability to do so.
Receives: Other: PNF

What is being measured

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

  1. Lower extremity functional scale

    a reliable patient-rated outcome measure for assessing lower extremity function. This is a 20-item self-report questionnaire. The highest attainable score is 80 points, signifying excellent function. The lowest possible score is 0, indicating very poor function. It has an outstanding internal reliability (=0.96) and a valid tool. It will be measured at baseline, 4th and 8th week

    Measured: 8 week

Secondary outcomes (3)

  1. Dynamic gait index

    It assesses the participant's ability to maintain walking balance while reacting to varied task demands under diverse dynamic settings. It is a beneficial test for those who have vestibular and balance issues, as well as those who are at danger of falling. It will be measured at baseline, 4th and 8th week

    Measured: 8 week

  2. Time Up and Go Test

    Time up and go test is a quick and widely used clinical performance-based measure of lower extremity function, mobility and fall risk with a specificity of 0.70 and sensitivity of 0.57 and reliability of 0.98.The higher the score reflects the worst functional status. It will be measured at baseline, 4th and 8th week

    Measured: 8 week

  3. Stroke Specific Quality of Life Scale

    It is a patient-centered outcome measure designed to assess health-related quality of life in stroke patients. Patients must answer each question with a reference to the previous week. It is a self-report measure with 49 items divided into 12 areas. A 5-point Likert scale is used to rate the items. The Cronbach alpha ranged from 0.75-0.89. It will be measured at baseline, 4th and 8th week

    Measured: 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 posted17 Jul 2023
  2. Study start24 Jul 2023
  3. Primary completion31 Dec 2023
  4. Study completion19 Jan 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
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05948384
Sponsor's protocol ID
REC01540 Shahnoor Syed
Status last verified
Mar 2024
First submitted
7 Jul 2023
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Amarenco P. Transient Ischemic Attack. N Engl J Med. 2020 May 14;382(20):1933-1941. doi: 10.1056/NEJMcp1908837. No abstract available.

    PubMed 32402163

  • Sherin A, Ul-Haq Z, Fazid S, Shah BH, Khattak MI, Nabi F. Prevalence of stroke in Pakistan: Findings from Khyber Pakhtunkhwa integrated population health survey (KP-IPHS) 2016-17. Pak J Med Sci. 2020 Nov-Dec;36(7):1435-1440. doi: 10.12669/pjms.36.7.2824.

    PubMed 33235553

  • Guiu-Tula FX, Cabanas-Valdes R, Sitja-Rabert M, Urrutia G, Gomara-Toldra N. The Efficacy of the proprioceptive neuromuscular facilitation (PNF) approach in stroke rehabilitation to improve basic activities of daily living and quality of life: a systematic review and meta-analysis protocol. BMJ Open. 2017 Dec 12;7(12):e016739. doi: 10.1136/bmjopen-2017-016739.

    PubMed 29233831

  • Gandhi DB, Sterba A, Khatter H, Pandian JD. Mirror Therapy in Stroke Rehabilitation: Current Perspectives. Ther Clin Risk Manag. 2020 Feb 7;16:75-85. doi: 10.2147/TCRM.S206883. eCollection 2020.

    PubMed 32103968

Questions about this trial

What is this clinical trial studying?

A study testing PNF in people with Stroke, run by Riphah International University 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 2 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 5 Mar 2024. 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?

Lower extremity functional scale (time frame: 8 week). 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 NCT05948384, which also lists 4 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 5 Mar 2024.

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Mirror Therapy Versus PNF on LE Function in Stroke | AzTrials