NCT05948384

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable stroke

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

First Submitted

Initial submission to the registry

July 7, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

July 24, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

July 7, 2023

Last Update Submit

March 4, 2024

Conditions

Outcome Measures

Primary Outcomes (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

    8 week

Secondary Outcomes (3)

  • Dynamic gait index

    8 week

  • Time Up and Go Test

    8 week

  • Stroke Specific Quality of Life Scale

    8 week

Study Arms (2)

PNF Group

ACTIVE COMPARATOR

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

Other: PNF

Mirror Therapy Group

OTHER

Mirror 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.

Other: PNF

Interventions

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

Mirror Therapy GroupPNF Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Institute of Rehabilitation Sciences

Abbottābād, Khyber Pakhtunkhwa, Pakistan

Location

Related Publications (4)

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

    PMID: 32402163BACKGROUND
  • 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.

    PMID: 33235553BACKGROUND
  • 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.

    PMID: 29233831BACKGROUND
  • 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.

    PMID: 32103968BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mirza Obaid Baig, MSPT

    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

July 7, 2023

First Posted

July 17, 2023

Study Start

July 24, 2023

Primary Completion

December 31, 2023

Study Completion

January 19, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations