Upper Extremity Training for Improving Balance Control Post-Stroke

NCT05049018 | Completed

• 1 other identifier: 14-MED98-10
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Postural balance control is based on complex mechanisms involving several sensory and motor systems. Maintaining postural equilibrium requires muscle activation to oppose the balance threats. Stroke may be associated with a variety of deficits, including impaired upper limb functions , poor postural stability, impaired reactive balance control, and delayed responses to external balance perturbations. Individuals with stroke are at high risk for falls in all post-stroke stages. Falls may have long-term serious consequences and can lead to more disability. Upper extremity movements have a relevant contribution in controlling balance and enhance the ankle and hip strategies for maintaining upright postural stability among healthy adults. Upper extremities movements also, constitute important elements in both equilibrium and protective reactions. Appropriate corrective responses of both the upper and lower extremities are essential to regain balance control and reduce the risk of falls. More studies are required to know about the impact of arm movements on postural balance control in individuals post-stroke. The purpose of this study is to investigate the effect of the improvement of the upper extremity functions on postural balance control in patients with stroke.

Conditions

Stroke

Keywords

Upper Extremity Functions; Balance Control; Postural Stability; Virtual Reality; Conventional Exercise Training

Outcome Measures

Primary Outcomes (3)

• Change in the score of Fugl-Meyer Assessment Scale of Upper-Extremity (scale that assess the change in upper extremity motor functions)

  The Fugl-Meyer Assessment of Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index. It measures the movement, coordination and reflex action of the shoulder, elbow, forearm, wrist and hand. The scale includes 33 items divided into 4 subscales: (A) shoulder/elbow, 18 items, (B) wrist, 5 items, (C) hand, 7 items, and (D) coordination/speed, 3 items. Each item is scored on an ordinal 3-point scale, where 2 points are assigned when the movement is performed fully, 1 point when performed partially, and 0 points when the movement cannot be performed. A total score of 66 indicates better sensorimotor function. Thus, the higher the score a patient will get after completion of the treatment program compared to the baseline score, the better the improvement in upper extremity motor functions.

  [Data collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between Fugl-Meyer Assessment Scale Score of Upper-Extremity at both baseline and completion of 12 weeks of intervention)

• Change in the score of Balance Subscale of the Fugl-Meyer Test (scale that designed to evaluate balance impairment after stroke.)

  Balance Subscale of the Fugl-Meyer Test is designed to evaluate balance impairment after stroke. It contains 7 items, 3 for sitting and 4 for standing. These items are sitting without support, parachute reaction (both sides), standing with and without support, unilateral stance (both sides). The seven items are rated on a 3-point scale (0-2). The total score is ranged from 0 to 14. This test is a valid and reliable clinical balance measures at different post-stroke stages of recovery.

  [Data collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between the scores of Balance Subscale of the Fugl-Meyer Test at both baseline and completion of 12 weeks of intervention)

• Change in the Overall Stability Indices {percentage value (%)} for Postural Stability Test (test that assess the change in postural stability)

  The Biodex Balance System will be used to assess the change in the Overall Stability Indices of the Postural Stability Test. The test includes measurement of the following indices: overall stability index, anteroposterior index and mediolateral index which represents the patient's ability to control his postural balance stability in all directions. High values % represent less stability and the patient has difficulty in balance control. On the other hand lower values are indicative of a better balance control.

  [Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between the overall stability indices score at both baseline and completion of 12 weeks of intervention)

Secondary Outcomes (2)

• Change in the Overall Directional Control Index {percentage value (%)}, for Limit of Stability Test (test that assess the change in balance ability)

  [Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between the overall directional control index at both baseline and completion of 12 weeks of intervention)

• Change in the Total Time of Control {seconds} for Limit of Stability Test (test that assess the change in total time required to complete limit of Stability Test)

  [Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between the total time required to complete limit of stability test at both baseline and completion of 12 weeks of intervention)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants who participated in the control group received a traditional physical therapy program for two hours. It included two parts, each of them was for one hour and 15 minutes rest in between. The first part included: muscle strengthening and facilitation exercises, stretching exercises, and postural reactions exercises. The second part included: functional exercise for facilitation of arm-reaching and arm-hand skills, manipulative tasks (grasping and release activities), and daily living activities for the affected upper limb. The traditional treatment program was applied for both groups by therapists, experienced in stroke rehabilitation. It was carried out three sessions per week for twelve successive weeks.

Other: Traditional Physical Therapy Program

Experimental Group

EXPERIMENTAL

Participants in the experimental group received two hours treatment program that included three parts, the first and the second parts (similar to that were applied for participants in the control group). These two parts were applied for one hour followed by 15 minutes rest, then the third part was applied for one hour. The third part of the program was a one-hour virtual reality intervention program by using (ArmeoSpring) virtual reality equipment to simulate a range of upper limb tasks that facilitate arm activities, manipulative skills, and daily living tasks through using different interactive games and soft-wares. The traditional treatment part of the program was applied by therapists, experienced in stroke rehabilitation. The virtual reality part of the program was applied by other experienced physiotherapists, who were well trained in using the (ArmeoSpring) System. All three parts of the program were carried out three sessions per week for twelve successive weeks.

Other: Traditional Physical Therapy Program; Device: ArmeoSpring Virtual Reality Device (Upper Extremity Training Device with Virtual Reality Technology)

Interventions

Traditional Physical Therapy Program OTHER

This intervention included: * Strengthening and facilitation exercises for the affected upper extremity muscles. * Stretching and mobilization exercises for the affected upper extremity muscles and joints. * Postural reactions exercises. * Facilitation of arm-reaching and arm-hand skills for the affected upper extremity. * Facilitation of manipulative tasks (grasp and release activities) for the affected upper extremity. * Training of daily living activities for the upper extremities.

Control Group; Experimental Group

ArmeoSpring Virtual Reality Device (Upper Extremity Training Device with Virtual Reality Technology) DEVICE

ArmeoSpring virtual Reality Equipment is a functional upper extremity rehabilitation device that provides specific therapy with augmented feedback. The ArmeoSpring instrument facilitates intensive task-oriented upper extremity therapy after stroke, traumatic brain injury, or other neurological diseases and injuries. It combines adjustable arm support, with augmented feedback and a large 3 D workspace that allows functional therapy exercises in a virtual reality environment.

Experimental Group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Umm Al Qura University

Mecca, Mecca Region, 21955, Saudi Arabia

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ehab M Abd El Kafy, PhD

  Faculty of Applied Medical Sciences - Umm Al Qura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors who performed all assessments throughout the study were not involved in the intervention program. They were not informed about which group; each evaluated patient was belong (blind assessors).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Therapy

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 17, 2021
• Study Start: January 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: December 10, 2022
• Last Updated: January 14, 2025

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Start Date: Beginning one year following main results publication End Date: Ending two years following main results publication
• Access Criteria: Data can be obtained by Principal Investigator Email Address: emkafy@uqu.edu.sa

Locations

SA (1)