NCT05059704

Brief Summary

Due to minimal volitional activation of the impaired arm, these individuals are less able to engage in activities of daily living (ADL's). Moreover, simultaneous use of the hand and arm are needed throughout ADL's. The effects of these two approaches (circuit class training and individual task-specific training) on upper extremity function and activities of daily living (ADL's) have not yet been clearly identified, and studies on its effects on chronic stroke patients are limited.

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 Jun 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

September 17, 2021

Last Update Submit

January 13, 2023

Conditions

Keywords

SpasticityMotor function

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment Scale

    The Fugl-Meyer Assessment is the gold standard to assess motor function of post-stroke hemiparesis. The Fugl-Meyer Upper Extremity (FMUE) Scale is a widely used and highly recommended stroke-specific, performance-based measure of impairment. It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia.

    8 weeks

Secondary Outcomes (2)

  • Modified Ashworth Scale

    8 weeks

  • Stroke Specific-Quality of Life Urdu Version (SS-QOL)

    8 weeks

Study Arms (2)

Circuit Class Training

EXPERIMENTAL

Patients will participate in a total of 1.5hour/day for 8 weeks with a 1:3 (therapist to patient). The circuit will be divided into 5 specific stations, 5 to 10 minutes for warm-up tasks and 15 to 20 minutes on each station as tailored to the patient's activity level

Other: Circuit Class Training

Individual Task specific training

ACTIVE COMPARATOR

Patients will participate in a total of 1.5hour/day for 8 weeks with 1:1 (therapist to patient) ratio. During each session, all patients will perform 5 to 10 minutes warm-up tasks, then practiced the selected tasks for the rest of the time.

Other: Individual Task specific training

Interventions

Station 1 will include tasks for warm-up specific for upper extremity, station 2 will include shoulder exercises, station 3 will include elbow exercises, station 4 will include wrist exercises and station 5 will include hand activities and functional training. Variables such as speed, or/and resistance will progressively increase in difficulty according to each patient's ability.

Circuit Class Training

Variables such as speed, or/and resistance will progressively increase in difficulty according to each patient's ability.

Individual Task specific training

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mini-Mental State Examination score more than 24
  • Chronic stage (i.e. post-stroke duration of 6 months)
  • Single episode of stroke
  • MAS of 1 to 3 at upper extremity.
  • MRS of ≤ 3 at lower extremity.
  • MCA stroke
  • Scores 32 to 47 on Fugl-Meyer Upper Extremity Scale (FMA-UE)

You may not qualify if:

  • Orthopedic conditions that affect the UE function.
  • Other neurological conditions, like PD, MS etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Mustafa Trust Medical and Physiotherapy Centre

Dhok Gujra, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

StrokeMuscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mirza Obaid Baig, MSPT(NMR)

    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

September 17, 2021

First Posted

September 28, 2021

Study Start

June 26, 2021

Primary Completion

July 31, 2022

Study Completion

August 31, 2022

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations