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Parkinson DiseaseNCT07263646

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

A study testing balance-focus exercise programe in people with Parkinson Disease and Gait Disorders, run by Ministry of Health, Kuwait at 1 site in Kuwait.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease, Gait Disorders, Gait Balance
What is being tested?
balance-focus exercise programe
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteKuwait
Study dates
22 Jan 2026to 22 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Esraa T Aldayil, PhD contact

00965 99980166

dresraa.aldayil@outlook.com

Hadeel H Alsaleh, PhD contact

0096565064141

golden_land85@hotmail.com

Kuwait1 site
  • Physical Medicine and Rehabilitation Center, Kuwait

    Kuwait City, 85001

    Esraa Aldayil, PhD, 00965 99980166, dresraa.aldayil@outlook.com

    hadeel H Alsaleh, PhD, 0096565064141, golden_land85@hotmail.com

Other trials in Kuwait

About this study

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.

Read the detailed description

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.

Being tested
balance-focus exercise programe
Keywords
gait initiation, Parkinson disease, rehabilitation, balance-focus exercise
Medical subject headings
Parkinson Disease, Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • balance-focus exercise programeOther

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

Study groups in NCT07263646
Study groupRoleWhat they receive
control groupNo interventionControl Group: Conventional Physiotherapy - Participants will receive standard physiotherapy interventions targeting gait and motor symptoms. Conventional Physiotherapy will include: * Balance and Postural Training, (e.g. bridging and rolling exercise), * Flexibility and Range of Motion (e.g. upper limb exercise include shoulder, elbow and wrist movements, lower limb exercise including hip, knee and ankle movement) * Strength Training focus on anti-gravity muscles (e.g. squatting, body-weight strengthening exercise) * Functional Mobility Training (e.g. Sit-to-stand practice and stairs training * gait training (e.g. Practice heel-to-toe walking, emphasize large, exaggerated steps, use visual cues and auditory cues, turn training: wide arc turning to avoid freezing, treadmill walking with therapist supervision) * home program.
intervention (treatment ) groupExperimentalParticipants will receive comprehensive balance-focused exercise programme integrated into conventional physiotherapy. The participants will be engaged in supervised sessions (by physiotherapists) of interactive balanced exercises focusing on improving balance, cognition, and coordination. The comprehensive balance-focused exercise programme will consist of motor tasks using interactive balance device to facilitate postural stability and weight-shifting control.
Receives: Other: balance-focus exercise programe

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. weight

    weight of the person in KG

    Measured: baseline

  2. height

    the height of the person in CM

    Measured: baseline

  3. gait analysis

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

    Measured: baseline

  4. Gait Analysis

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

    Measured: 6 weeks

  5. gait analysis

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

    Measured: 10 weeks

  6. • electromyography (EMG)

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

    Measured: baseline

  7. electromyography EMG

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

    Measured: 6 weeks

  8. electromyography EMG

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

    Measured: 10 weeks

Secondary outcomes (8)
  1. Parkinson severity scale (PDQ-39)

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

    Measured: baseline

  2. Parkinson severity scale PDQ-39

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

    Measured: 6 weeks

  3. Parkinson severity scale PDQ-39

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

    Measured: 10 weeks

  4. Timed Up and Go test (TUG)

    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

    Measured: baseline

  5. Timed Up and Go test TUG

    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

    Measured: 6 weeks

  6. time up and go TUG

    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

    Measured: 10 weeks

  7. PITTSBURGH rehabilitation participation scale

    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.

    Measured: 6 weeks

  8. patient satisfaction

    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)

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2025
  2. Study start22 Jan 2026 (estimated)
  3. Primary completion22 Dec 2027 (estimated)
  4. Study completion22 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
parallel group prospective (10 weeks) randomised single-blinded controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07263646
Sponsor's protocol ID
2824/2025
Status last verified
Dec 2025
First submitted
15 Jul 2025
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: IPD collected in this research will be owned by the ministry of health in Kuwait and restrictions apply to the availability of these data publicly. however, IPD can be available from authors upon resonable request and with permission of the ministry of health

Publications

  • 1- Hassler, R. (1967) 'Private communication to O'. Hornykiewicz. Letter dated February, 9 1967. 2- Lanciego, J.L., Luquin, N. and Obeso, J.A. (2012) 'Functional neuroanatomy of the basal ganglia'. Cold Spring Harbor perspectives in medicine, 2 (12), pp. a009621. 3- Breniere, Y. and Do, M.C. (1991) 'Control of gait initiation'. Journal of motor behavior, 23 (4), pp. 235-240. 4 -Grosset, D., Fernandez, H., Grosset, K., & Okun, M. (2009). Parkinson's Disease: Clinican's Desk Reference. CRC Press. 5 Cau, N., Cimolin, V., Galli, M., Precilios, H., Tacchini, E., Santovito, C., & Capodaglio, P. (2014). Center of pressure displacements during gait initiation in individuals with obesity. Journal of neuroengineering and rehabilitation, 11(1), 1-8. 6- Mickelborough, J., Van Der Linden, M., Tallis, R., & Ennos, A. (2004). Muscle activity during gait initiation in normal elderly people. Gait & posture, 19(1), 50-57. 7- Stone, E. E., Skubic, M., & Back, J. (2014). Automated health alerts from kinect-based in-home gait measurements. 2014 36th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, 8 - Lelard, T., Doutrellot, P.-L., Temfemo, A., & Ahmaidi, S. (2017). Electromyographic pattern during gait initiation differentiates yoga practitioners among physically active older subjects. Frontiers in human neuroscience, 11, 300. 9 Ivanenko, Y.P., Poppele, R.E. and Lacquaniti, F., 2004. Five basic muscle activation patterns account for muscle activity during human locomotion. The Journal of physiology, 556(1), pp.267-282. 10- Berardelli, A., Rothwell, J. C., Thompson, P. D., & Hallett, M. (2001). Pathophysiology of bradykinesia in Parkinson's disease. Brain, 124(11), 2131-2146. 11 -Sherbondy, P. S., Queale, W. S., McFarland, E. G., Mizuno, Y., & Cosgarea, A. J. (2003). Soleus and gastrocnemius muscle loading decreases anterior tibial translation in anterior cruciate ligament intact and deficient knees. The journal of knee surgery, 16(3), 152-158

Questions about this trial

What is this clinical trial studying?

A study testing balance-focus exercise programe in people with Parkinson Disease and Gait Disorders, run by Ministry of Health, Kuwait at 1 site in Kuwait.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Esraa T Aldayil, PhD (00965 99980166, dresraa.aldayil@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

weight (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07263646, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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