search
Back to results

Circuit Class Training vs. Individual, Task Specific Training in Chronic Stroke Patient

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Circuit Class Training
Individual Task specific training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Spasticity, Motor function

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Sites / Locations

  • Al Mustafa Trust Medical and Physiotherapy Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Circuit Class Training

Individual Task specific training

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Modified Ashworth Scale
The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone. The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform
Stroke Specific-Quality of Life Urdu Version (SS-QOL)
The SS-QOL scale is a health-related outcome measure that comprises 49 items in 12 areas of vision, mobility, thinking, social roles, self-care, language, personality, family roles, work/productivity, upper limb function, mood and energy. It covers a more extensive inclusion of capacities ordinarily influenced by stroke.

Full Information

First Posted
September 17, 2021
Last Updated
January 13, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05059704
Brief Title
Circuit Class Training vs. Individual, Task Specific Training in Chronic Stroke Patient
Official Title
Effects of Circuit Class Training vs. Individual, Task Specific Training on Upper Extremity Function in Chronic Stroke Patient
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 26, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
several research found that circuit training improved various functional parameters after stroke. And most of the circuit based tasks from the published studies were focused on the leg strength, walking speed, distance and balance etc. Previous literature found that circuit class training is effective in improving upper extremity function in chronic stroke patients disregarding the type of stroke and the results of that study are not generalized for chronic stroke patients with upper extremity deficit. Secondly, circuit class training and task-specific training are effective for improving upper limb function following a stroke but in the acute stage. In fact, there is no evidence in which comparison of these two approaches has been done in chronic stroke patients and thirdly, between these two approaches which approach is more effective towards improving upper limb function in chronic stage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Spasticity, Motor function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Circuit Class Training
Arm Type
Experimental
Arm Description
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
Arm Title
Individual Task specific training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Circuit Class Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Individual Task specific training
Intervention Description
Variables such as speed, or/and resistance will progressively increase in difficulty according to each patient's ability.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment Scale
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale
Description
The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone. The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform
Time Frame
8 weeks
Title
Stroke Specific-Quality of Life Urdu Version (SS-QOL)
Description
The SS-QOL scale is a health-related outcome measure that comprises 49 items in 12 areas of vision, mobility, thinking, social roles, self-care, language, personality, family roles, work/productivity, upper limb function, mood and energy. It covers a more extensive inclusion of capacities ordinarily influenced by stroke.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Orthopedic conditions that affect the UE function. Other neurological conditions, like PD, MS etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirza Obaid Baig, MSPT(NMR)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al Mustafa Trust Medical and Physiotherapy Centre
City
Gujrāt
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Circuit Class Training vs. Individual, Task Specific Training in Chronic Stroke Patient

We'll reach out to this number within 24 hrs