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NCT Number: NCT07263646

The Effect of Balance-focused Exercise Programme in Enhancing the Solus-muscle Activation During Gait Initiation for People With Parkinson Disease

Gait initiation (GI) is a crucial component of walking that requires a balanced muscle activity and postural stability. GI could be challenging for people with neurological condition such as people with Parkinson (PWP), where GI is usually impaired. The purpose of this study is determining effectiveness of comprehensive, balanced-focused exercise programme in controlling the activation of Solus-muscle in people with Parkinson disease. We hypothesise that balance-focus exercise programe could improve Solus-muscle activation during GI.

study type: this is a parallel group prospective (10 weeks) randomised single-blinded controlled trial conduct in Kuwait.

Participant: People with Parkinson, who met the inclusion criteria.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Medicine and Rehabilitation Center, Kuwait

Kuwait City, 85001, Kuwait

Location contact

Esraa Aldayil, PhD

CONTACT

[email protected]

00965 99980166

dana j alsaqer, PhD

SUB_INVESTIGATOR

esraa T Aldayil, PhD

PRINCIPAL_INVESTIGATOR

hadeel H Alsaleh, PhD

CONTACT

[email protected]

0096565064141

hadeel h Alsaleh, PhD

SUB_INVESTIGATOR

About this study

Parkinson's Disease (PD), a neurodegenerative disorder characterised by motor dysfunction . The basal ganglia play a significant role in regulating muscle excitation, and its dysfunction in PD leads to abnormal activation patterns in muscles such as the soleus, crucial for walking. This contributes to symptoms like bradykinesia, resulting in slower movement, shuffling gait, and difficulty initiating walking. Prolonged activation of the plantar flexor muscles, especially the soleus, disrupts the forward momentum needed for normal walking.

Gait initiation (GI) is a crucial component of walking that requires a balanced muscle activity and postural stability. The GI process requires a propulsive force to move the body across a distance (from a bipedal stance to repeating gait cycles) while maintaining postural stability. Thus, GI could be challenging for people with neurological condition such as people with Parkinson (PWP), where GI is usually impaired.

Any modification to the GI program could affect postural stability and the velocity of the movement and any impairment in muscle activation of the lower limb will interfere with the GI process, .

This underscores the significance of the altered muscle excitation pattern observed in PWP and its potential impact on motor control. This imbalance can contribute to the prolonged muscle activation times and differential speed changes observed in muscle activation patterns.

Bradykinesia is a slow movement during the execution of common physical activities, such as the activities of daily living (ADL). That could be because PWP tend to keep the plantar flexor muscles mainly (solus) contracted for longer time. This prolonged muscle activity interferes with the gravity-assisted forward rotation of the body resulting adverse affects on the timing of subsequent events during gait initiation.

Therefore, therapies aimed at restoring the balance during GI may help improve motor control and balance in individuals, thus improve GI speed with Parkinson's disease.

Balance-focused rehabilitation strategies, including interactive exercises, are promising in addressing delays in GI. Several previous studies explored the effect of balance exercise of the GI in patients with Parkinson. For example, in a systematic exploration of cueing therapy's impact on gait and balance in individuals with Parkinson's disease, revealed its efficacy. This approach, the cueing therapy was highlighted as a promising intervention for addressing gait and balance challenges in Parkinson's disease. Another significant approach for functional rehabilitation is the utilization of balance boards, as underscored by. Investigating the effectiveness of a Wii Fit™-based balance board exercise program in the elderly population. Consequently, Mhatre et al. concluded that the Wii Fit™ balance board exercise program represents a valuable tool for augmenting balance and mitigating fall risk among older adults. In the context of functional rehabilitation, these interventions, particularly cueing therapy and balance board exercises, signify promising avenues for improving motor function and addressing challenges associated with gait and balance. Consideration of these therapeutic approaches is crucial for devising comprehensive and effective rehabilitation strategies tailored to the unique needs of individuals undergoing functional rehabilitation.

However, there is a need for further research to explore effective rehabilitation strategies tailored to different disease severity levels. To improve the maintenance and rehabilitation of community walking ability in PWP, there is a need to understand the details of the kinematics, as well as the muscle activation characteristics during while GI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • participants diagnosed by their neurologist with Parkinson's disease (moderate to severe stage)
  • stable on anti-Parkinson's drugs
  • able to walk independently without a frame or walking stick.
  • Able to walk for more than 10 mins unaided
  • without cognitive disability (Able to follow simple instructions and communicate, orally),
  • have good vision (with or without corrective aids)

Exclusion criteria

  • are pregnant
  • cardiac problems exacerbated by exercise
  • currently complaining of joint or muscle problems that affect walking ability
  • known to have neurological conditions (other than Parkinson) that affect walking ability
  • uncorrected hearing or vision problems
  • history of severe motion sickness
  • history of vestibular or balance problems
  • an active skin condition that could be irritated by contact with sticky tape.

Treatment and study plan

balance-focus exercise programe

Other

participants in the experimental group will receive balance-focused exercise programe integrated into conventional physiotherapy programe provided to people with parkinson.

Primary outcomes

  1. weight

    Time frame: baseline

    weight of the person in KG

  2. height

    Time frame: baseline

    the height of the person in CM

  3. gait analysis

    Time frame: baseline

    • Three-dimensional motion analysis:Motion capture units will track the movement of reflective markers placed on the skin/clothing of participants.
  4. Gait Analysis

    Time frame: 6 weeks

    Three-dimensional motion analysis: Motion capture units will track the movement of reflective markers placed on the skin/clothing of participants.

  5. gait analysis

    Time frame: 10 weeks

    Three-dimensional motion analysis: Motion capture units will track the movement of reflective markers placed on the skin/clothing of participants.

  6. • electromyography (EMG)

    Time frame: baseline

    Electric activity of the muscles using the wireless EMG measurement system. The system will track the activity of solus muscle (left and right).

  7. electromyography EMG

    Time frame: 6 weeks

    Electric activity of the muscles using the wireless EMG measurement system. The system will track the activity of solus muscle (left and right).

  8. electromyography EMG

    Time frame: 10 weeks

    Electric activity of the muscles using the wireless EMG measurement system. The system will track the activity of solus muscle (left and right).

Secondary outcomes

  1. Parkinson severity scale (PDQ-39)

    Time frame: baseline

    To evaluate the impact of Parkinson's disease on different dimensions of a patient's life and monitor changes over time.

  2. Parkinson severity scale PDQ-39

    Time frame: 6 weeks

    To evaluate the impact of Parkinson's disease on different dimensions of a patient's life and monitor changes over time.

  3. Parkinson severity scale PDQ-39

    Time frame: 10 weeks

    To evaluate the impact of Parkinson's disease on different dimensions of a patient's life and monitor changes over time.

  4. Timed Up and Go test (TUG)

    Time frame: baseline

    widely used clinical test to assess a person's mobility, balance, walking ability, and fall risk. It is especially useful in older adults and individuals with neurological or musculoskeletal impairment

  5. Timed Up and Go test TUG

    Time frame: 6 weeks

    widely used clinical test to assess a person's mobility, balance, walking ability, and fall risk. It is especially useful in older adults and individuals with neurological or musculoskeletal impairment

  6. time up and go TUG

    Time frame: 10 weeks

    widely used clinical test to assess a person's mobility, balance, walking ability, and fall risk. It is especially useful in older adults and individuals with neurological or musculoskeletal impairment

  7. PITTSBURGH rehabilitation participation scale

    Time frame: 6 weeks

    a clinician-rated tool used to measure a patient's level of participation in inpatient rehabilitation therapy sessions. It focuses on observed engagement, effort, and motivation.

  8. patient satisfaction

    Time frame: 6 weeks

    in response to the question how satisfied are you with the results of physiotherapy treatment? Patient will be asked tp grade their level of satisfaction on 5 points liked scale (1. Not at all satisfied, 2. Dissatisfied, 3. Natural, 4. Satisfied, 5. Very satisfied)

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa T Aldayil, PhD

CONTACT

[email protected]

00965 99980166

Hadeel H Alsaleh, PhD

CONTACT

[email protected]

0096565064141

Sponsors and collaborators

Lead sponsor

Ministry of Health, Kuwait

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 4, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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