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

NCT07263646 | Not Yet Recruiting DMC

• 1 other identifier: 2824/2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gait Disorders; Gait Balance; Parkinson Disease

Keywords

gait initiation; Parkinson disease; rehabilitation; balance-focus exercise

Outcome Measures

Primary Outcomes (8)

• weight

  weight of the person in KG

  baseline

• height

  the height of the person in CM

  baseline

• gait analysis

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

  baseline

• Gait Analysis

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

  6 weeks

• gait analysis

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

  10 weeks

• • 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).

  baseline

• 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).

  6 weeks

• 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).

  10 weeks

Secondary Outcomes (8)

• Parkinson severity scale (PDQ-39)

  baseline

• Parkinson severity scale PDQ-39

  6 weeks

• Parkinson severity scale PDQ-39

  10 weeks

• Timed Up and Go test (TUG)

  baseline

• Timed Up and Go test TUG

  6 weeks

Study Arms (2)

control group

NO INTERVENTION

Control 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 ) group

EXPERIMENTAL

Participants 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.

Other: balance-focus exercise programe

Interventions

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.

intervention (treatment ) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ministry of Health, Kuwait: lead

Study Sites (1)

Physical Medicine and Rehabilitation Center, Kuwait

Kuwait City, 85001, Kuwait

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Esraa T Aldayil, PhD

CONTACT

00965 99980166; dresraa.aldayil@outlook.com

Hadeel H Alsaleh, PhD

CONTACT

0096565064141; golden_land85@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the outcomes assessor will not be aware of the group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief of physiotherapy

Model Details: parallel group prospective (10 weeks) randomised single-blinded controlled trial

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: December 4, 2025
• Study Start: January 22, 2026
• Primary Completion (Estimated): December 22, 2027
• Study Completion (Estimated): December 22, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

KU (1)