NCT05026099

Brief Summary

The World Health Organization's (WHO) definition of stroke is a clinical syndrome characterized by rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours or leading to death with no apparent cause other than a vascular origin'.Stroke has further three types i.e. ischemic, hemorrhagic, and transient ischemic stroke. As most gestures in daily life involve the upper limbs and hands, patients who cannot use their hands not only suffer from severe physical and psychological pain but also encounter difficulties in the activities of daily living that primarily involve upper limb function. Stroke patients have various problems such as asymmetrical posture, abnormal body balance, and decreased ability to move the weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Aug 2021

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

Study Start

First participant enrolled

August 15, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2022

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

August 23, 2021

Last Update Submit

February 23, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Fugl-Meyer Assessment

    A three-point ordinal scale is used to measure impairments of volitional movement with grades ranging from 0 (item cannot be performed) to 2 (item can be fully performed). Specific descriptions for performance accompany individual test items. Subtests exist for Upper extremity function, Lower extremity function, balance, sensation, Range of Motion, and pain. The cumulative test score for all components is 226 with availability of specific subtest scores (e.g., Upper extremity maximum score is 66, Lower extremity score 34; balance score 14)

    week 8

  • Wolf Motor Function Test

    the Wolf Motor Function Test consists of 17 items Composed of 3 parts: * Time * Functional ability * Strength Includes 15 function-based tasks and 2 strength-based tasks Performance time is referred to as Wolf Motor Function Test-Time. Functional ability is referred to as Wolf Motor Function Test. Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks Examiners should test the less affected upper extremity followed by the most affected side. Uses a 6-point ordinal scale "0" = "does not attempt with the involved arm" to "5" = "arm does participate; movement appears to be normal." The maximum score is 75 Lower scores are indicative of lower functioning levels Wolf Motor Function Test Time allows 120 seconds per task

    week 8

  • Berg Balance Scale

    The maximum score that can be reached is 56 and each item possesses an ordinal scale of five alternatives ranging from 0 to 4 points.

    week 8

Secondary Outcomes (1)

  • Stroke Specific Quality of life

    week 8

Study Arms (2)

Boxing training program

EXPERIMENTAL

The program will start with a warm-up session involving breathing and stretching of the trunk and limbs for 5 minutes. The program will include mitt hitting and sand bag hitting for 10 minutes, with a 2-minute rest period. Thereafter, stretching of the trunk and limbs will be performed for 5minutes, similar to the warm-up

Other: Boxing training

Task Oriented Training Program

ACTIVE COMPARATOR

Upper limb Exercises: Sitting position: open covered pots of different sizes and transfer the flour to a cup with a spoon, then close the pot.Sitting position: pick up coins and cards on the table and put the coins in a pot and gather the cards.Sitting position: write and/or draw pictures on a piece of paper.Sitting position: open a safe box with a key, pick up small objects inside the box, and transfer them to a pot, then lock the safe box Sitting position: pick up and transfer jars, bottles, and glasses of different sizes and weights located on a table. Transfer the liquid contents from jars and bottles to glasses Sitting position: throw and catch balls (in pairs)

Other: Task Oriented Training

Interventions

Boxing training: warm-up. Mitt hitting, sandbag hitting, in sitting, cool down, Assessment after 4 weeks boxing training: warm-up. Mitt hitting, sandbag hitting, below hips, cool down, Assessment after 6 weeks Boxing training: warm-up. Mitt hitting, sandbag hitting, both inn sitting and standing, cool down, Post assessment

Boxing training program

Task-oriented training: 6 tasks in sitting and standing position for both upper and lower limb Assessment after 4 weeks Task oriented training: 6 tasks in sitting and standing position for both upper and lower limb Assessment after 6 weeks Task oriented training: 6 tasks in sitting and standing position for both upper and lower limb Post assessment

Task Oriented Training Program

Eligibility Criteria

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

You may qualify if:

  • Both genders
  • Age 40-60years
  • Middle Cerebral Artery Stroke
  • Fugyl Meyer score limit for upper limb:
  • Sub-acute and chronic (after 6 weeks)
  • Able to sit for 2mints independently

You may not qualify if:

  • Cognitive impairment
  • Abnormal synergic pattern
  • Rheumatoid arthritis or other hand impairments
  • Visual Impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iradah Rehabilitation Center Kalar Kahar

Chakwal, Punjab Province, Pakistan

Location

Related Publications (8)

  • Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.

    PMID: 23652265BACKGROUND
  • Ersoy C, Iyigun G. Boxing training in patients with stroke causes improvement of upper extremity, balance, and cognitive functions but should it be applied as virtual or real? Top Stroke Rehabil. 2021 Mar;28(2):112-126. doi: 10.1080/10749357.2020.1783918. Epub 2020 Jun 23.

    PMID: 32574096BACKGROUND
  • Duncan PW, Horner RD, Reker DM, Samsa GP, Hoenig H, Hamilton B, LaClair BJ, Dudley TK. Adherence to postacute rehabilitation guidelines is associated with functional recovery in stroke. Stroke. 2002 Jan;33(1):167-77. doi: 10.1161/hs0102.101014.

    PMID: 11779907BACKGROUND
  • Park J, Gong J, Yim J. Effects of a sitting boxing program on upper limb function, balance, gait, and quality of life in stroke patients. NeuroRehabilitation. 2017;40(1):77-86. doi: 10.3233/NRE-161392.

    PMID: 27792020BACKGROUND
  • Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.

    PMID: 21571152BACKGROUND
  • Kwakkel G, van Wegen EEH, Burridge JH, Winstein CJ, van Dokkum LEH, Alt Murphy M, Levin MF, Krakauer JW; ADVISORY group. Standardized Measurement of Quality of Upper Limb Movement After Stroke: Consensus-Based Core Recommendations From the Second Stroke Recovery and Rehabilitation Roundtable. Neurorehabil Neural Repair. 2019 Nov;33(11):951-958. doi: 10.1177/1545968319886477. Epub 2019 Oct 29.

    PMID: 31660781BACKGROUND
  • Feys HM, De Weerdt WJ, Selz BE, Cox Steck GA, Spichiger R, Vereeck LE, Putman KD, Van Hoydonck GA. Effect of a therapeutic intervention for the hemiplegic upper limb in the acute phase after stroke: a single-blind, randomized, controlled multicenter trial. Stroke. 1998 Apr;29(4):785-92. doi: 10.1161/01.str.29.4.785.

    PMID: 9550512BACKGROUND
  • Rodriguez GM, Aruin AS. The effect of shoe wedges and lifts on symmetry of stance and weight bearing in hemiparetic individuals. Arch Phys Med Rehabil. 2002 Apr;83(4):478-82. doi: 10.1053/apmr.2002.31197.

    PMID: 11932848BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Arshad Malik, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 30, 2021

Study Start

August 15, 2021

Primary Completion

August 20, 2022

Study Completion

August 20, 2022

Last Updated

February 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations